TOPICAL DISCUSSION

OF THE

NRC / AGREEMENT STATE PROGRAM

October 1994

Prepared by

Organization of Agreement States

Published by

Illinois Department of Nuclear Safety

PREFACE

The evolvement of the NRC/Agreement State Program covers a span of some

35 years. It has been, and continues to be, unique in the arena of federal-

state programs.

At the 1993 meeting of the Organization of Agreement States (OAS), a

suggestion was made that the collective body of Agreement States and the U.S.

Nuclear Regulatory Commission were losing the historical perspective of this

unique program and that some effort might be made to assure the retention of

this perspective. Therefore, the Executive Committee of the OAS appointed an

ad hoc committee to document the important aspects of the development of the

program. The committee decided to adopt a topical approach rather than a

strict historical or chronological approach. This was because there is no

formal documentation readily available to the OAS that would support the

latter approach, nor are the resources available to OAS to prepare a more

complete document. The committee recognizes that there may be gaps in its

report due to the lack of records and documentation or due to our failing

memories.

We hope that this document will benefit those Agreement State program

directors and staff members and the NRC staff who will succeed the current

generation. It should provide an institutional record, albeit modest, and

therefore be useful in considering future actions that may affect Agreement

State programs.

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The following individuals prepared initial drafts of the discussions in

Section VIII on selected technical issues:

Kirk Whatley, Alabama and Richard Ratliff, TexasTerry Frazee, Washington

William Spell, Louisiana Virgil Autry, South Carolina

Aubrey Godwin, Arizona Eddie Fuente, Mississippi

Tom Hill of Georgia prepared the initial draft of Section VII. Several other

Agreement State officials or former officials made valuable contributions to

the efforts of the committee.

Original signed by:

G. Wayne Kerr ____________________________

G. Wayne Kerr, Illinois Chairman, Ad Hoc Committee

Original signed by: Edgar D. Bailey

____________________________

Edgar D. Bailey, California

Original signed by: Aubrey V. Godwin

____________________________

Aubrey V. Godwin, Arizona

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ACKNOWLEDGEMENTS

The committee appreciates the contributions of many Agreement State

representatives in the preparation of this report. In addition, the assis-

tance of NRC staff is appreciated, particularly Lloyd Bolling who provided

copies of some of the records utilized in this effort. The committee sought

the comments of the following individuals on the draft:

Joel Lubenau, Technical Assistant to Commissioner E. Gail de Planque, NRC

Kathleen Schneider, Office of State Programs, NRC

Donald Nussbaumer, Assistant Director for State Agreements, OSP, NRC, 1980-1988

John Vaden, Nevada Dept. of Human Resources

Charles Hardin, Executive Director, CRCPD *

Janet Kerr provided assistance as a consulting editor. Gail Snider

of the Illinois Department of Nuclear Safety (IDNS) provided the clerical

support. Ann Frescura of IDNS designed the cover.

The assistance of the IDNS in preparing the report for publication is

greatly appreciated.

* The Conference of Radiation Control Program Directors (CRCPD) is anincorporated organization of the representatives of 49 state radia-tion control programs plus several local radiation programs. Itsactivities are much broader in scope than those of the Organizationof Agreement States, and there is no organizational relationshipbetween the two entities.

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TABLE OF CONTENTS

Preface ................................................................ ii

Acknowledgements ....................................................... iv

I. Introduction ..................................................... 1

II. Section 274 of the Atomic Energy Act ............................. 2

III. Unique Features of Agreement State Programs ...................... 5

IV. Routine Relations of NRC and Individual Agreement States ........ 12

V. Annual Meetings of All Agreement States ......................... 16

VI. AEC/NRC Officials and Organization .............................. 19

VII. Active Phase of Organization of Agreement States ................ 23

VIII. Perspectives on Selected Technical Issues ....................... 25

A. Regulation of Medical Uses of Radioactive Materials ......... 25

B. Regulation of Industrial Radiography ........................ 33

C. Generally Licensed Devices .................................. 38

D. Uranium/Thorium Mill Regulation ............................. 43

E. Regulation of Low-Level Waste Disposal ...................... 49

F. Regulation of Naturally Occurring and Accelerator-Produced Radioactive Materials (NARM) ........... 62

IX. Current Issues .................................................. 67

X. Epilogue ........................................................ 70

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APPENDICES

Appendix A List of Agreement States ................................. 72

Appendix B List of Annual Joint Meetings ............................ 75

Appendix C Chairpersons of Organization of Agreement States ......... 76

Appendix D Letter dated March 3, 1964 and Agenda for Exchange of Information Meeting with Texas ............. 78

Appendix E Letter dated Dec. 13, 1965, AEC to Texas with Results of Review Meeting .............................. 81

Appendix F Letter dated April 3, 1992, NRC to Maine ................. 83

Appendix G Agenda for Dec. 14-15, 1964 Meeting of AEC and All Agreement States ................................... 85

Appendix H Agenda for Oct. 24-27, 1993 Meeting of NRC and All Agreement States ................................... 86

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1 The terms AEC and NRC are used interchangeably in this document,particularly where the dates of certain events are not known.

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TOPICAL DISCUSSION OF THE NRC/AGREEMENT STATE PROGRAM

"States are not mere political subdivisions of the United States. State governments are neither regional officesnor administrative agencies of the Federal Government. The positions occupied by state officials appearnowhere on the Federal Government's most detailed organizational chart. The Constitution instead ‘leaves tothe several States a residuary and inviolable sovereignty,’ the Federalist No. 39, p. 245 (C. Rossiter ed. 1961),reserved explicitly to the States by the Tenth Amendment." Cited in decision of the Supreme Court of theUnited States, Nos. 91-543, 91-558, and 91-563, June 19, 1992.

I. Introduction

The NRC/Agreement State program has been in existence for more than 30years. Its genesis actually began several years before the first stateentered the program in 1962. The states were showing signs of restlessness asearly as 1954 over their role in the regulation of nuclear materials andfacilities. The resulting 1959 amendment to the Atomic Energy Act of 1954established the statutory framework for what has become known as the AgreementState program.

The program was initially developed and administered by the regulatory armof the U.S. Atomic Energy Commission (AEC). These functions were transferredto the U.S. Nuclear Regulatory Commission (NRC) on Jan. 19, 1975 when the AECwas abolished and the NRC was created by the enactment of the Energy Reorgani-zation Act of 1974.1 This change came about after several years of concernthat there was an inherent conflict of interest in having the AEC be thepromoter of uses of atomic energy and its nuclear weapons development programwhile also being the regulator of some of those activities. Interestingly,the state of Arizona established an Atomic Energy Commission in its initialstage following the AEC pattern. This agency was abolished in 1980 forconflict of interest reasons after a serious incident (the American Atomicsincident, see p. 10). A few other states initially had development agenciesalso, which will be discussed in Section III.

The program established by the 1959 amendment to the Atomic Energy Act wasunique in that it involved a discontinuance of regulatory authority by the AECand assumption of that authority by the states. The federal government hadexercised this authority in an area where authority was traditionally exer-cised by state and/or local governments. Further, the legislation did notestablish a delegated program as was the case for federal programs in someother areas. Thus, the program was a reversal of the traditional solution tosuch issues. The traditional approach to emerging issues was that the federalgovernment only stepped in when an issue became national in scope that mightjustify some federal action. As Roy Parker, former program director inLouisiana, frequently reminded us, the federal government was only involved

2 See Appendices A and B, National Bureau of Standards Handbook 61, thatincorporates recommendations of the National Committee on Radiation Protec-tion. The Preface to this handbook is of particular interest, indicating NCRPstudies on this issue began in early 1953.

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because of the development of atomic energy during World War II. Absent thattraumatic event, there might well have never been an Agreement State program.

This report will focus on a number of significant areas in the developmentand implementation of the NRC/Agreement State program. These areas includelegislative initiatives as well as programmatic functions, organizationalaspects and technical issues. The report is thus organized in a topicalfashion as opposed to an historical approach. The report should provide someperspective to future state and federal officials on key developments in theprogram.

II. Section 274 of the Atomic Energy Act

Section 274 was added to the Atomic Energy Act of 1954 (AEA) on Sept. 23,1959. This was the culmination of much effort by the U.S. Congress and manystate and federal officials and organizations. The most comprehensivebackground on circumstances leading up to this amendment are found in refer-ences 1 and 2. Section 271 of the AEA of 1946 and of 1954 had some referencesto state functions, but it was not clear that this extended to the areas ofhealth and safety.

The AEC's Director of Regulation (or equivalent) formed an AdvisoryCommittee of State Officials in late 1955 that first met in February 1956. The committee served to advise the AEC during the consideration of thefederal/state relations issue and for a period of time after enactment ofsection 274. We are unaware of when the advisory committee was disbanded, butbelieve it was in the mid-to-late 1960s. The New England Governor's Confer-ence Committee on Atomic Energy recommended a model state bill in 1955. Thestate of New Hampshire, in August 1955, passed an act that established a statepolicy, authorized studies related to atomic industrial development, providedfor coordination of studies and development activities, and provided themodest sum of $1,000 for certain related expenses. A suggested state radia-tion protection act and suggested regulations were published as early asDecember 9, 1955.2

Other states followed with legislation, some of which related to develop-ment and others to regulatory programs. Many of these followed the style andcontent of model legislation published by the Council of State Governments(COSG) in 1957. The COSG also published model legislation in 1961 addressingthe subjects of coordination of atomic energy activities, enabling authorityto enter into regulatory agreements with the AEC, and providing three optionsfor administrative organizations covering development, coordination andregulatory functions. It included a provision to "permit maximum utilizationof sources of ionizing radiation consistent with the health and safety of thepublic." Several states used this model legislation in developing theirlegislation. A few states, notably Mississippi and Michigan, through theopinion of their Attorneys General, determined that special enabling legisla-

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tion was not needed for their states. Another notable provision of the modellegislation was that it was not limited to agreement materials. Rather, itcovered all sources of ionizing radiation, and thereby established a basis fora comprehensive radiation control program for any state that followed themodel legislation.

In 1983 the COSG published a new version of the Suggested State Legisla-tion at the recommendation of the NRC. It included new specific provisionsrelated to the regulation of low-level radioactive waste and ofuranium/thorium processing facilities. It also deleted some of thedevelopmental aspects of the previous model legislation.

By mid-1958, 13 states had authorized the establishment of an Office ofCoordinator for Atomic Energy Activities or a similar position (Reference 1,page 154, footnote 1). There appeared to be a conscious effort by the statesto avoid imposing any requirements that might hamper the development of atomicenergy.

The Joint Committee on Atomic Energy of the U.S. Congress (JCAE) collecteda large volume of materials related to federal-state cooperation in the fieldof atomic energy (reference 1). On Feb. 11, 1959, the JCAE wrote a letter tothe governors of each state announcing a hearing to be held in May 1959 toconsider legislative proposals in this area. The letter invited the states toparticipate in the hearings. Prior to this the AEC had proposed a bill in1957 that would have permitted dual regulation of what has become known asagreement materials (source, byproduct and small quantities of special nuclearmaterial).

The lead-off witness at the May 19, 1959 hearing was Professor G. HoytWhipple of the University of Michigan School of Public Health. One particu-larly interesting statement Dr. Whipple made was, "I believe that today thesum total of the greatest exposure to people in the United States comes fromthe medical uses of x-ray." (Reference 2, p. 10). Seems like deja vu in the1990s. Numerous witnesses appeared at the hearings, including several fromthe AEC, state officials and their organizational representatives, organizedlabor and representatives of industry or other users of radioactive material. The testimony was far-ranging, covering subjects such as AEC operations, wastedisposal, training, inspections, reactor hazards and of course, states'rights. Commissioner Graham of the AEC testified that "it would be desirableto enact legislation to clarify the role of the States at an early date." (Reference 2, p. 289). Organized labor generally opposed the bill beingconsidered by the committee which would give the states a regulatory role overagreement materials. Labor felt it was a federal responsibility to controlradiation hazards. Mr. Leo Goodman, of the United Auto Workers (UAW),recommended it be rejected in toto since it would dilute the AEC's responsi-bility. However, Goodman stated that the UAW supported the development ofthis science. Organized labor also seemed to feel the states were not capableof regulating these materials. The hearings continued on May 20, 21, and 22,1959.

A final day of hearings was held on Aug. 26, 1959, with several witnessesfrom the AEC led by Chairman McCone. The JCAE received specific comments onboth Senate and House bills regarding a new section 274 on Cooperation withStates. The AEC generally supported the bills but had reservations regardingthe establishment of a Federal Radiation Council, which was also opposed by

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the Bureau of the Budget. A letter submitted later on the same day of thehearing by the AEC's General Manager stated the AEC "did not intend to leaveany room for the exercise of concurrent jurisdiction by the States..."(Reference 2, p. 500). The JCAE reported out both bills on Aug. 31, 1959, andthe legislation was signed into law on Sept. 23, 1959. Although the actprovided for training and other assistance to states without charge, the JCAEmade it clear that cash grants were not to be provided.

The 1959 amendment stood unchanged for nearly 20 years when the UraniumMill Tailings Radiation Control Act of 1978 was passed. This act imposedcertain additional requirements on states that wished to continue regulatinguranium or thorium mills and tailings (paragraph o of section 274). This cameabout because of questionable authority of AEC over tailings at closed millsand problems associated with the environmental impact of these tailings. Further, section 274j was amended at this time to require the NRC to periodi-cally review agreements and actions taken by the states under the agreementsto ensure compliance with the provisions of section 274 of the Act.

Section 274 also was amended in 1980 by the modification of paragraph jregarding temporary suspensions of agreements in emergency situations. Thiswas a result of the 1979 American Atomics incident in Arizona noted in SectionI. As a result, Congressman Udall of Arizona held hearings on the AgreementState Program on July 19, 1979. The temporary suspension amendment iscommonly referred to as the DeConcini amendment. DeConcini is a senator fromArizona who sponsored the legislation. The only other amendment to section274 was made in 1983 when the last paragraph of section 274o was added.

Section 274 provides for discontinuance of regulatory authority by the NRCfor source material, byproduct material (two kinds) and small quantities ofspecial nuclear material. Naturally occurring and accelerator producedmaterials (NARM) are not subject to the Atomic Energy Act. This is presumablybecause of a reluctance by Congress to provide the AEC with any authority overradioactive materials beyond those associated with the atomic energy program,such as certain naturally occurring radioactive material, and a reluctance tointrude on what was presumably already subject to state jurisdiction throughgeneral public health responsibilities. The preemption provisions of the actonly applied to the materials specified and, of course, over major nuclearfacilities such as reactors. In addition, at the time of the 1959 amendment,the states might have been opposed to AEC regulation of NARM. This will bediscussed further in Section VIII.

One other unique feature of section 274 is that the program provided inparagraph (b) is a discontinuance of authority by the NRC and the assumptionor exercise of authority by the state on the effective date of an agreement. This can be contrasted with many federal-state programs that provide fordelegated authority and, in many cases, include federal monies for the state. Many today seem to lose sight of this feature, and in the view of some itappears that the NRC currently searches for some way to impose uniformity onthe Agreement States even in the absence of a good health and safety reason. Most Agreement States feel that adequacy of their programs is the only testrequired by section 274j after agreements are in place. Further, they feelthat in the absence of operating funds provided by the NRC, they should havethe freedom to manage their programs with considerable flexibility.

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III. Unique Features of Agreement State Programs

A. Criteria, Conditions Fostering Agreements, and Agreement Forms

To implement the new law, one of the AEC's first chores was to developcriteria to evaluate the applications of states desiring to achieve agreementstatus. After consulting with a number of groups of state officials, includ-ing the AEC's Advisory Committee of State Officials, other state organizationsand individual states, industry, labor and several other federal agencies, thedraft criteria were published for public comment in early 1960. In April1960, President Eisenhower solicited comments from the governors on the draftcriteria. In early 1961 the AEC staff provided revised criteria to theCommission, and final criteria were published in the Federal Register onMarch 24, 1961. The criteria covered areas such as radiation protectionstandards, prior evaluation of uses, inspections, enforcement, personnelqualifications, conditions applicable to special nuclear material (particular-ly the formula for small quantities that Agreement States could regulate),administration, arrangements for discontinuing AEC jurisdiction and reciproci-ty. The criteria were modified on Jan. 23, 1981 to include requirements foruranium/thorium processing Agreement States, and on July 21, 1983 withadditional provisions related to disposal of radioactive waste. The finalcriteria in 1961 deleted the proposed requirement that state standards be "nomore and no less" than AEC standards (Reference 5, p. 297) that were includedin the draft criteria. Further, the criteria were intended to be used asguidelines for the factors that the AEC would consider in evaluating a state'sproposal (46 FR 7540, Jan. 23, 1981).

Soon after enactment of section 274, several states began active prepara-tions to assume this new regulatory authority. Agreements could not beconsummated immediately, however, since each state would have to achieveseveral actions. They needed to enact enabling legislation, draft andpromulgate rules, hire and train staff, obtain the necessary funds to supportstaff and buy equipment, and negotiate the details of the agreement packagewith the AEC. The AEC initially had a State Relations Branch in its Regulato-ry Division of Radiation Standards that handled the negotiations with assis-tance from other AEC offices, including the General Counsel.

A beneficial side effect of states preparing for agreement status was thatit usually enhanced their program for regulation of non-agreement material andx-ray machines. Some had little or no regulatory program for those sources. By obtaining gubernatorial and legislative support for the agreement program,the states frequently obtained the support necessary for a more comprehensiveradiation control program, which was felt to be a significant advantage tobecoming an Agreement State. In some cases, additional support was given bythe U.S. Public Health Service (PHS) by the placement of assignees in thestates. Sometimes they worked in x-ray and sometimes in radioactive materi-als. In any event, it was a useful supplement to the state and in turn,provided field experience for the PHS staff. The activities of the SouthernInterstate Nuclear Board (SINB) and Western Interstate Nuclear Board (WINB)also helped generate interest in the program among high-level state officials(governors and legislators), which might not have been possible otherwise. Many of the early Agreement States were from the South and West where states'rights attitudes were strong. Thus, this program appealed to those states.

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As indicated earlier, the AEC could not provide operating cash grants tostates but did provide valuable training and technical assistance. Likewise,the PHS provided some more limited training. Further, the U.S. Department ofHealth and Welfare (or equivalent) originally provided category grants tostate programs. In 1969, it shifted to a block grant approach, and stateradiation control programs may have indirectly received money through thismechanism. In the 1970s and 1980s, the AEC did consider "seed money" fortrying to obtain new Agreement States, but was unsuccessful. Some AEC stafffelt this effort would not have been successful in any event. (One provisionfor giving grants will be discussed in Section VIII.D.) One more exotic ideaadvanced by some AEC staff was the walk-away proposal whereby AEC would simplyquit regulating in the materials area and leave it up to the states bydefault. This would, of course, have required legislation. Although dis-cussed as an option from time to time, it was considered unrealistic. In1994, NRC again considered seed money in a response to a request from theState of Oklahoma. The result of this reconsideration was that NRC againdetermined that it did not have explicit legal authority and that it was aconsistent and long-standing Commission policy not to provide seed moneygrants to support preparations of an Agreement State program. Also in lightof the 100% fee support of the NRC by its licensees, there is an equity issuewith the NRC licensees supporting such a program.

The agreements entered into with each state followed a reasonablystandardized pattern. They all contained several "Whereas" statements ofpurpose and findings followed by several articles on the authority beingtransferred, the authority reserved to the AEC, authority for the AEC toreserve additional functions in the future, reservations to the AEC of commondefense and security and safeguards functions, a best efforts article tomaintain coordinated and compatible programs, a reciprocity article, atermination article and an effective date article. A significant change wasmade in the best efforts article with the fourth state, New York. The firstthree agreements placed emphasis on the state using its best efforts tomaintain compatibility with the AEC. At the request of New York, the articlewas changed in its agreement pledging both New York and the AEC to use theirrespective best efforts to maintain compatible programs with the AEC and otherAgreement States (Reference 6, attachment, p. 7). This change was included inall subsequent agreements. However, even this did not lay to rest the issueof continuing compatibility, which in 1994 is still an issue between the NRCand the Agreement States.

The agreements were generally signed by the AEC Chairman or delegatedCommissioner and the Governor of the state. Some states had joint formalsigning ceremonies in their capital city and other agreements were signed bycorrespondence without a ceremony. Appendix A shows a list of AgreementStates with their effective dates and a list by year of the agreement.

Many of the early radiation programs were organizationally a part of aState Health Department. Later, several were in environmental departments,and two were free-standing cabinet level agencies (Arizona and Illinois). Theprogram directors frequently were engineers with training in radiation orother environmental aspects. However, the following initial directors werephysicians:

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New York Department of Labor Morris Kleinfeld, M.D.Florida Ed Williams, M.D.North Carolina William Wilson, M.D.Oregon Oscar Schneider, M.D.Tennessee Curtiss McCammon, M.D.

To our knowledge, no subsequent directors have been physicians.

B. Features of Individual Agreement State Programs

As indicated previously, the state radiation control programs were notidentical organizationally in terms of their parent agency or style. Discus-sion of some of the unique aspects of several Agreement State programs andcircumstances regarding negotiation of their agreements follows.

The first state we examine is Kentucky, which became the first AgreementState on March 26, 1962. Attorney General John Breckinridge was a keyindividual in negotiating the agreement with the AEC. Kentucky had estab-lished an Atomic Energy and Space Authority that conducted promotionalactivities, of which Breckinridge was the chairman. However, the regulatoryprogram was organizationally located in the Health Department. Duringconsideration of the application submitted by Kentucky, controversy arose overwhether the state should regulate land disposal of radioactive wastes andwhether the state should regulate the manufacture and distribution of productscontaining radioactive material (Reference 5, pp. 299 and 300). The AECapparently questioned the ability of the state on the waste issue and wasconcerned about uniformity in evaluation and distribution of products ininterstate commerce. Regarding the waste issue, one AEC official was quotedas saying, "‘if states assume jurisdiction in this matter, each state wouldwant a burial site within its borders’" (Reference 5, p. 299) - a view thatcan be contrasted with the prevailing attitude of states in 1994. Afterconsideration of the issues, the Kentucky agreement was consummated andallowed the state to regulate low-level waste disposal on land and to regulatedevices containing radioactive material except for those in consumer products(these products came to be known as exempt distribution products). A pictureof the signing of the Kentucky agreement is shown in Fig. 1. Three days afterthe signing, Chairman Seaborg addressed a joint session of the Kentuckylegislature. The state indeed licensed a land-disposal facility located nearMorehead, Kentucky in 1963. The common feeling among Kentucky officials wasthat this action would encourage other nuclear facilities, including powerplants, to locate in the area. This, of course, soon was shown to be a falsehope. Further, as noted in Section VIII.E., this site experienced technicaloperating problems in the mid-1970s.

The next state to enter the agreement program with unique features wasCalifornia on Sept. 1, 1962. The California program was unique in that otherstate agencies and local agencies carried out some inspections for thecentralized Health Department program. These included the state's Division ofIndustrial Safety, Los Angeles County Health Department and Orange CountyHealth Department, and were known as contract agencies. They did not havelicensing authority. The second unique aspect of the California program was

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3 AEC's first fee program for materials licensees was established Oct. 1,1968, but did not cover all categories of materials licensees at that time. 4 Letter dated June 20, 1994 from J. Vaden to W. Kerr.

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5 The Bureau of Radiation Control in the New York State Department ofEnvironmental Conservation was established July 1, 1970 to handle environmen-tal issues and low-level waste.

the establishment of fees. The fee system was based on the form of material(sealed or unsealed) and the curie quantity. Later, most fee systems adoptedby the NRC and other Agreement States were based on the category of licenseeand the type of program they conducted (e.g., radiography, medical, academic,etc.). The California fee program generated considerable discussion andconcern within the AEC as to whether it would be compatible with the AECprogram without fees.3 The finding of the Commission was "How a statefinances its regulation of materials under an agreement should not be aconcern of the Commission."4 One non-regulatory Division Director of the AECwas very concerned over the decision since he felt it might curtail the use ofradioisotopes. AEC still had a heavy promotional bent at that time.

In addition to the aforementioned change to the best efforts article ofthe agreement, there were other unique aspects of the New York program. NewYork's program included three separate agencies, each of which issued rules,licensed material users, inspected licensees and took enforcement actionsagainst licensees. These agencies were the New York State Department ofLabor, New York State Department of Health and New York City Department ofHealth.5 Labor regulated industrial concerns throughout the state includingNew York City; State Health regulated academic and medical licensees outsideof New York City; and City Health regulated academic and medical users withinNew York City. Originally, the Health Departments regulated the environmentalrelease aspects of Labor Department licensees. The agencies operated indepen-dently, but a coordinating group called the Committee on Licensing (COL) wasestablished in the state's Office of Atomic and Space Development. Although the word "Development" was part of the agency's title, in actuality it mostlydid planning and inter-agency coordination. This office was organizationallylocated in the governor's office. The principal contact for the COL wasRobert Vessels in the early years and the COL coordinated regulatory functionsof the affected agencies. A significant technical difference from the AEC inthe New York program was a variation in occupational dose limits. New Yorkhad based its limits regarding quarterly doses on guidance from the FederalRadiation Council and the National Committee on Radiation Protection andMeasurements (Reference 6, attachment, p. 16). New York allowed 13-weekexposures of 3 rem, whereas AEC only allowed 1¼ rem per quarter unless anoccupational history was maintained and accumulated doses could not exceed5(N-18) where N was the age in years. The AEC finally concluded that theregulations were compatible. The New York negotiations were consummated at alate date. Vessels handled the logistics for New York State. It is ourrecollection that the AEC Commissioners approved the agreement on Oct. 14,1962 and it was signed by Chairman Seaborg. Vessels returned to Albany latethat day and obtained Governor Rockefeller's signature so the agreement wouldbe effective on October 15. Vessels sent a telegram to Ben Harless, Chief ofthe AEC's State Agreements Branch that evening that said, "The pony is in thebarn."

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The New Hampshire agreement became effective May 16, 1966. The uniquefeature of this agreement was that it was signed by six individuals for thestate. The agreement was signed by Governor John King and co-signed by thefive members of the Governor's Executive Council, which was a statutoryrequirement of the state.

The Louisiana agreement became effective May 1, 1967. Louisiana estab-lished a Board of Nuclear Energy with two components: the Atomic EnergyDevelopment Agency and the Division of Radiation Control. Although the twogroups shared offices, they functioned independently. In 1973, the Divisionof Radiation Control was merged into the Division of Natural Resources. TheBoard of Nuclear Energy was abolished and the development activities graduallyfaded away. The negotiations with Louisiana were probably the most difficultof any Agreement State. The main issue of contention involved the regulationof Louisiana licensees (and other jurisdiction's licensees operating underreciprocity) in disputed areas of off-shore coastal areas. At the time of theagreement negotiations, the state of Louisiana and the United States ofAmerica were involved in a cause pending before the U.S. Supreme Court. Atstake were vast sums of money that would accrue to either party from offshoreoil and gas drilling operations, depending on the outcome of the case. Oneother consideration was that it affected only persons operating in thedisputed area or seaward thereof and that were on or in the seabed or struc-tures affixed thereto (primarily drilling rigs). The AEC acknowledged theexisting practice of the Agreement States having authority to regulate theircitizens on the high seas, i.e., unattached vessels. The negotiations onbehalf of AEC were elevated to the level of Eber Price, Director, Division ofState and Licensee Relations and Howard Shapar, Associate General Counsel. This dilemma was solved by the development of two documents in addition to thestandard agreement. The first was a Memorandum of Understanding that wasbasically a disclaimer of any effects on the pending Supreme Court case. Thesecond additional document was a section 274i inspection agreement. Theagreement permitted the state to perform, without charge, inspections of AEClicensees, for and on behalf of the AEC, in the areas subject to the litiga-tion. These inspections were to be performed subject to AEC supervision andto certain restrictions regarding enforcement. The three documents weresigned at a ceremony in Baton Rouge, Louisiana, on April 17, 1967. Commis-sioner Wilfrid Johnson signed on behalf of the AEC and Lieutenant GovernorAycock on behalf of Governor McKeithen. This is believed to be the only casewhere the Lieutenant Governor signed for a state. Dr. Roy Parker, Director ofthe Louisiana Division of Radiation Control, co-signed the Section 274iagreement.

The Arizona agreement became effective May 15, 1967. As noted in SectionI of this report, the state established the Arizona Atomic Energy Commission(AAEC) following the pattern of the U.S. AEC. The agency was a cabinet-levelagency that had both promotional and regulatory functions. After a seriousincident at an industrial licensee's facility in Tucson in 1979, whichresulted in extremely large releases of tritium to the surrounding neighbor-hood, the Arizona AEC was abolished and a new cabinet-level Radiation Regula-tory Agency was established July 31, 1980. An obvious conflict of interestsituation came to the forefront during the course of the incident and wasaddressed by the governor and state legislature. Among other things, thesitting Chairman of the AAEC at the time of the incident was a top executiveof the licensee involved.

6 Judging a small state's capability was always difficult because the totaleffort required to conduct the program was probably less than a full person-year. NRC generally followed the practice of requiring a state to have atleast two qualified professionals on staff even though they might spend partof their time on such other duties as x-ray or environmental programs.

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The next state that faced a unique situation in achieving agreement statuswas Rhode Island. Rhode Island was a state with a very small program (about50 licensees) and was negotiating in the aftermath of the Arizona incident andthe July 1979 Udall hearing. The NRC's Office of Nuclear Materials Safety andSafeguards raised concerns about the Rhode Island staffs' capability.6 Inaddition, the NRC's Commissioner Gilinsky, who testified for the NRC at theUdall hearing, was pushing for more rigorous standards by which to judgeAgreement States. Jim Hickey, Director of the Rhode Island program, and DanteIonata of the governor's office appeared before the Commission in late 1979 topresent the state's case. In sum, they stated that if Rhode Island's applica-tion was turned down on anything other than health and safety grounds, thestate would pursue other actions. The Commission approved the Rhode Islandagreement, which became effective Jan. 1, 1980. The approval was by splitvote (3-2) with Commissioners Gilinsky and Bradford opposed. This is the onlystate of which we are aware where the state appeared before the Commission orwhere the decision was by split vote.

The New Mexico agreement became effective May 1, 1974. Upon passage ofthe Uranium Mill Tailings Radiation Control Act of 1978 on Nov. 8, 1978(UMTRCA), Agreement States that wished to continue regulating uranium millshad three years to upgrade their programs (see Section VIII.D). This periodwas later extended and although New Mexico did considerable work to try andachieve an amended agreement, it was unsuccessful. The main reason was theopposition by the uranium milling industry to the proposed regulations, which,of course, pursuant to UMTRCA, were closely patterned after those of NRC. Thus, Governor Anaya of New Mexico requested that the NRC reassert authorityover uranium milling in New Mexico and the NRC did so effective June 1, 1986. The basis for the request was the inability to adopt regulations and a lack ofresources. Ironically, the industry then became subject to almost identicalregulations of the NRC although objected to when proposed by New Mexico.

The Illinois agreement became effective June 1, 1987. The question oftransfer of authority of one source material license became an issue in thiscase. Allied Chemical Corp. operates a UF6 conversion plant for uranium(source material) at Metropolis, Ill. It is one of two such conversion plantsin the United States, the other being in a non-Agreement State. Ordinarily,the authority over this licensee would transfer to the state on the effectivedate of the agreement. The NRC, after receiving advice from the U.S. Depart-ment of Energy, decided to retain jurisdiction over this licensee in order toprotect the common defense and security. Commissioner Asselstine opposed thedecision. Chairman Zech's letter to Governor Thompson informed him of theapproval of the agreement and of the decision on Allied Chemical but stressedthat the decision was not reflective of Illinois' ability to regulate thelicensee for health and safety purposes. This is the only case we know ofwhere a single license was not transferred because of common defense andsecurity considerations.

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Idaho became an Agreement State on Oct. 1, 1968. On April 26, 1991, Idahovoluntarily relinquished its agreement authority. The state had chronicfunding and staffing problems and was unable to obtain the necessary supportfrom its legislature. The NRC never formally moved to revoke this agreement,but rather put pressure on Idaho to either get the program in shape orrelinquish its authority. The matter was discussed at the Synar hearing onAug. 2, 1993 and is discussed in the next section.

IV. Routine Relations of NRC and Individual Agreement States

A. Individual Agreement State Relations

In the early phase of the NRC/Agreement State program, the AEC institutedmeetings with each individual Agreement State on a periodic basis. In fact,these early meetings were usually done by invitation of the state. They wereintended to implement the best efforts articles of each agreement. These werelabeled, "Exchange of Information" meetings, and a typical agenda for such ameeting is shown in Appendix D. The emphasis was clearly on a two-wayexchange of information. Each party relayed information regarding incidentsor events, regulation changes, inspection information and general informationon regulatory matters. Typically, the AEC was represented by one or two staffmembers of the State Agreements Branch and one from the AEC region, frequentlythe regional director or the materials branch chief. The state was normallyrepresented by the program director and most of the materials staff. Themeetings usually lasted one to two days, and contacts were not usually madewith senior state management officials. There was no organized aspect ofreview and evaluation by the AEC staff, however, they sometimes offeredsuggestions and were certainly willing to offer the benefit of their experi-ence to the state officials.

Before long, however, the AEC staff began developing a list of questionsin their own area of expertise to guide themselves in developing an opinion asto how the state was managing its agreement materials program. A major changein the direction of the program came about in May 1965. The U.S. Departmentof Labor (DOL) was proposing to impose regulatory requirements duplicative ofthose imposed by the AEC and Agreement States on their respective licensees. The DOL was using the authority of the Walsh-Healey Public Contracts Act. Itis believed that there were Congressional hearings on the matter with strongobjection by the states and the AEC. The AEC negotiated the issue with theDOL, and the quid pro quo arrangement was that the AEC would make an annualformal redetermination of compatibility for all Agreement States and DOL wouldnot impose dual regulation on these licensees. This recognition of the AEC'sdetermination was later incorporated into the Occupational Safety and HealthAct, which superseded the Walsh-Healey Act. Another notable event in thisregard was that in 1965 the Commission chose not to go forward with proposedlegislation that would have given AEC the authority to terminate agreementsbased on incompatibility. Even earlier, in 1963, the AEC determined that"‘unilateral power to require compatibility would appear to be inconsistentwith both the nature of the program established and the underlying philosophyof the statute’." (Reference 6, attachment, pp. 8 and 10.) The first formalredetermination of compatibility by the Commission was made on Jan. 5, 1966.

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This approach was abandoned in 1982 when it was realized the redeterminationsfor many states were up to two years old, and it would be more useful for theNRC staff to meet periodically with the DOL staff to discuss areas of mutualinterest and to provide the DOL with information when significant concernarose. In any event, the 1965 change in policy required the AEC staff to takean evaluative approach to the individual Agreement State programs. Appendix Eshows an early letter to a state following the review of its program afterthis new evaluation process was implemented.

In 1973, the AEC staff formalized the guidance that they had been usingfor several years in evaluating Agreement State programs. The staff publisheda "Guide for Evaluation of State Radiation Control Programs Under Agreement"that did not have the stature of the later and more formal 1981 policystatement of the NRC on this subject. Nevertheless, the 1973 guide containedmany of the same elements of review that appeared in the 1981 and subsequentpolicy statements. Essentially, these documents covered the major categoriesof legislation and regulations, organization, management and administration,personnel, licensing and compliance. Although the meetings with individualAgreement States continued to include an element of information exchange, theybecame longer and were structured differently. [One former state programdirector continued to call them Exchange of Information (EOI) meetings longafter the change had taken place.] The NRC staff began to review licensefiles, including the backup material, inspection and enforcement actions,response to incidents, laboratory support, and staffing and personnel activi-ties. One other practice that was instituted was the accompaniment ofAgreement State inspectors. Initially, these were carried out by regional AECstaff members who had materials inspection experience. As the State Agree-ments Branch added staff with licensing and inspection experience, the AECregions stopped participating in the review meetings and no longer performedaccompaniments. This came as a result of a recommendation by John Davis, thenDirector of the AEC's Region II office in Atlanta, Ga. Davis had beenparticularly helpful in assisting states in that region and in helping theState Agreements Branch. Within the AEC, he no doubt had the best understand-ing of the agreement state program outside of the Division of State andLicensee Relations.

Another important aspect of the AEC review process was that the criteria,and more particularly the internal procedures of the AEC, were intended to beused as guidance by AEC staff. As noted above, the earlier documents weretitled as guides and the Agreement States were furnished copies of them sothey knew what elements were included in the reviews. Their use was to betempered with good judgement by people knowledgeable about radiation regulato-ry programs. They were not intended to be used by "bean counters" - acontemporary term that has been applied to certain aspects of reviews andtheir results. The results of these more formal reviews were discussed withstate management officials at the conclusion of their review visit. The NRC'sconclusions and recommendations were then sent to the senior state managementofficial (e.g., State Health Officer), and in most cases with a request for aresponse on the recommendations. However, the State Agreements Officers inthe regions conducted many of the reviews (See Section VI).

The review process continued along these lines for many years. NRC'sOffice of State Programs did supplement its reviewers with staff from otherNRC offices on an ad hoc basis in such areas as uranium mill regulation, low-level radioactive waste disposal, and sealed source and device reviews. In

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the late 1980s, NRC made another change in its review process. It began toorganize team reviews, in some cases quite large, for the review of the largerAgreement State programs. Usually the lead reviewer and team coordinator wasthe Regional State Agreements Officer for the region in which the particularstate was located. The team could consist of staff with various specialtiesfrom NRC's Office of Nuclear Material Safety and Safeguards, occasionally theOffice of Nuclear Reactor Regulation, other regions and occasionally someother office. Of course, the use of out-of-region personnel negated one ofthe advantages of having a State Agreements Officer in each region, namelycost savings accrued by reduced travel expenses. Smaller Agreement Stateprograms continued to be reviewed by the regional State Agreements Officer.

Aside from the periodic review meetings with individual Agreement States,the NRC's post-agreement program contained other elements. All of these wereintended to carry out the best efforts articles for coordination and coopera-tion. It also was deemed necessary to carry out the provision of section274a.(3) to "promote an orderly regulatory pattern between the Commission andstate governments...".

One of the other key parts of the program was technical assistance to theAgreement States. This assistance took several forms. The most frequent wasoral advice given by the staff of the Office of State Programs (OSP) or otherNRC staff on a large variety of technical and regulatory matters. Another wayof obtaining such assistance was for the Agreement State to submit a writtenrequest to the NRC and to receive a written response. These requests werenormally coordinated by OSP, which obtained the necessary information fromappropriate NRC offices. This coordination was particularly useful to theAgreement States so as to avoid having to locate the appropriate staffmember(s) in other NRC offices to provide the information. Less frequently,technical assistance was made available to the Agreement State at its officesfor very specialized issues and for assistance on complex inspections.

Another key part of the NRC's assistance program was, and is currently,its training program. Starting with the earliest Agreement States, the AECrecognized the need to provide some specialized training to states preparingto become Agreement States or after their agreements became effective. Thefirst course was a three-week orientation course on regulatory practices(covering both licensing and inspection functions). It was recognized thatstate officials had basic knowledge in radiation safety and in some cases,experience in x-ray regulation or NARM control. However, the AEC's regulatoryprogram was somewhat unique, so courses were tailored to that aspect ofregulation. The time progression for the various courses is not known;however, courses were developed in basic health physics, radiation protectionengineering, licensing procedures, inspection procedures, transportation,medical uses, well logging, industrial radiography, uranium mill regulation,waste disposal, and other areas. Many of these are still offered today andare extremely valuable to the Agreement States.

A fourth element of the NRC's post agreement program is the exchange ofinformation program. This covers the distribution of regulatory informationnecessary for the NRC and Agreement States to carry out their respectiveprograms in an efficient and orderly fashion. The type of information to bedistributed by the NRC and to be sent to the NRC by Agreement States wasordinarily covered in an exchange of letters with each new Agreement State. The information typically covered regulatory guides, sealed source and device

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evaluation sheets, statistical data on licensing and inspections, exemptdistribution licenses, all licenses issued by the state, incident information,draft regulation changes, NRC bulletins and information notices, NUREGdocuments and various other regulatory documents of general interest. Much ofthis exchange continues today, although some is requested in conjunction withthe review meetings. Appendix F shows an April 3, 1992 letter to Maineestablishing such an exchange.

The fifth principal element of the post-agreement program is of morerecent vintage. Beginning in the late 1980s, the NRC has hosted a number ofworkshops to address specific regulatory issues. Workshops have been held onlow-level waste regulation, uranium/thorium mill regulation, industrialradiographer certification, regulation of medical uses, megacurie irradiationfacilities, and evaluation of sealed sources and devices. The AgreementStates have, in general, found these to be very useful. They provide anopportunity to discuss each participant's views on an issue and sometimes cometo a consensus on a given regulatory approach. In some cases, the AgreementStates have been able to persuade the NRC to make significant changes inregulatory approaches - most notably in industrial radiography certificationand medical use of radioactive materials.

B. Reviews by the U.S. General Accounting Office (GAO)

GAO is an arm of the U.S. Congress and generally conducts reviews andaudits of federal agencies on its own initiative or at the specific request ofCongress. The first comprehensive review of the AEC's management and over-sight of the Agreement State program was conducted about 1972. The Committeedoes not have access to the GAO report resulting from that review, but it isrecalled that relatively modest recommendations were made. The formalizationof the 1973 review guide referenced in IV.A. above may have resulted from theGAO recommendations. Also, there were likely follow-up reviews to thatinitial comprehensive review.

GAO has performed a number of other reviews of NRC activities over theyears. Several of these have been related to low-level waste disposal and theNRC's materials regulatory program. Frequently these reports have coveredcertain aspects related to Agreement States, since they conduct independentbut integral parts of these functional areas.

In April 1993, GAO issued a report titled, "Better Criteria and Data WouldHelp Ensure Safety of Nuclear Materials," GAO/RCED-93-90. This report wasprepared in response to a request from Congressman Mike Synar, Chairman,Environment, Energy, and Natural Resources Subcommittee, House Committee onGovernment Operations. The purpose of the review was stated to be (1) thereview of the comparability of NRC's programs for Agreement States and NRC-regulated states, including assessments of the effectiveness of both programs,and (2) follow-up on previous recommendations in a 1988 report (not related tothe Agreement State program). The 1993 report recommended (1) that the NRCestablish common performance indicators to evaluate the Agreement Stateprograms and NRC's regulatory program, and (2) that specific criteria andprocedures for suspending or revoking an Agreement State program be developed. The GAO spent very little time during its review with Agreement State offi-cials and never discussed its findings with any of the Agreement States priorto publication. Congressman Synar held a lengthy hearing on Aug. 2, 1993 atwhich GAO, OAS and NRC testified. At that hearing, GAO stated that it never

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found an Agreement State program inadequate, but that it was questionable ifthe public is being adequately protected by the state-regulated or NRC-regulated programs. NRC was questioned extensively on its oversight programwith particular emphasis on so-called problem Agreement States. These werestates where NRC had withheld findings of adequacy and/or compatibility forlengthy periods, or were unable to make findings as a result of its reviews. As this document is being written, NRC is wrestling with what changes shouldbe made, both in its relationship to Agreement States and in the NRC oversightprogram.

The Synar hearing followed on the heels of a May 6, 1993 hearing bySenator John Glenn, Chairman, Senate Committee on Governmental Affairs, on theregulation of medical uses of radiation. This hearing was a result of aseries of articles that appeared in the Cleveland Plain Dealer in December1992. The articles covered a number of medical-related radiation incidentsinvolving agreement materials, x-ray machines and linear accelerators in bothAgreement and non-Agreement States. Aubrey Godwin, Past Chairman, CRCPD,testified at that hearing. As a result of that hearing and because of anextremely serious incident that occurred on Nov. 16, 1992 in Pennsylvania, anon-Agreement State, the NRC is making a number of changes in its program forregulation of nuclear materials used in the medical area. Some of thesechanges could well affect how Agreement States regulate medical uses.

V. Annual Meetings of All Agreement States

The AEC began holding joint meetings with all Agreement States, apparentlyin 1964. A list of these meetings is shown in Appendix B. This was anothereffort to keep the Agreement States informed of significant regulatorydevelopments at the AEC. The Agreement States were requested to submit topicsthey wanted discussed at the meeting. The AEC tried to select topics thatwould be of broad interest, rather than an issue relating to only 1 or 2states. Most of the early meetings were held in the Washington, D.C. area. Frequently, an AEC Commissioner or the Director of Regulation (the ExecutiveDirector for Operations in NRC) would present opening remarks. Appendix Gshows the agenda for the Dec. 14-15, 1964 meeting.

One advantage of holding the meeting in the Washington, D.C. area was thatif individual state officials needed to meet with other AEC staff, suchmeetings could be arranged. Secondly, staff from other AEC offices werereadily available to discuss topics without costly travel. In the earlymeetings, most of the topics were presented by AEC staff, although there wasample opportunity for dialogue between the state officials and the AEC staff. Officials from the FDA and EPA and the federal representatives to the Southernand Western Interstate Nuclear Boards usually were invited to the meetings.

The Agreement State representatives were never shy about expressing theiropinions to the AEC staff. At one early meeting, there was a presentation bythe AEC's Harold Kneeland on its attempt to initiate a program for theretention of personnel monitoring records and the reporting of certain datafrom selected groups of licensees to the AEC to be maintained in a central

7 Kneeland was substituting for Charles Eason, who had formerly beenAssistant Director of AEC's Division of State and Licensee Relations.

8 See 10 CFR 20.1501(c).

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repository.7 This is the provision of AEC/NRC regulations currently containedin Section 10 CFR 20.2206 (formerly 20.407). The AEC wanted the AgreementStates to participate in this program and would, to the best of ourrecollection, provide some monies to Agreement States to do so. This proposalprompted a heated discussion by the Agreement State representatives and theAEC staff. It was perhaps a portent of things to come several years later onissues such as certification of industrial radiographers, medical misadminis-tration rules, compatibility and others. The state officials' primary concernwas that personnel monitoring records were not that reliable because of theimprecision of doses recorded on film badges. This, of course, predated therequirement for personnel dosimeters to be processed and accredited byprocessors accredited by the National Voluntary Laboratory AccreditationProgram (NVLAP).8 The Agreement States were generally opposed to being forcedto participate in this program and to implementing similar regulations. Webelieve few, if any, Agreement States ever participated.

This particular discussion had both a serious aspect and a humorous twist. Sometime during the heat of the discussion, Mr. Jon Anderson of New York leftthe meeting to visit Mr. Harold Price, Director of Regulation. He informedMr. Price that the Agreement States were adamantly opposed to any suchrequirements being imposed on them or their licensees, and it would be wisefor the AEC to back off from their position. The AEC followed this wisecounsel, and Agreement States were not required to adopt similar regulations. In NRC's Internal Procedure B.7, "Criteria for Compatibility Determinations,"this rule is listed in the Division 3 category, which Agreement States havethe choice to adopt or not. This rule is not included in the current versionof the CRCPD's Suggested State Regulations for Control of Radiation, but willbe included as an optional provision in the next version. Mr. Eber Price,Director, Division of State and Licensee Relations, had chaired the meeting. In a post-mortem discussion of the meeting with his staff, Price remarked thatDr. Curtiss McCammon of Tennessee made a slip of the tongue when he referredto the futility of placing these records of little value in a radiationrecords suppository. The staff informed Mr. Eber Price that they believedDr. McCammon had stated precisely what he intended.

The agendas for these early meetings show that topics typically coveredmedical uses of radioactive materials, industrial radiography, problems withgenerally licensed devices, waste disposal, transportation of radioactivematerials and many others. Many of these subjects continue to be discussed inthe more recent meetings. The early meetings were heavily dominated by AECstaff presentations, although the discussions were frequently active andfrank. Beginning perhaps in the mid-1970s, more presentations were made bystate officials, although few states volunteered. Usually NRC staff recruitedstate staff to discuss various topics. However, in some cases, AgreementState requests to speak were denied. Also, starting about 1980, the agendafrequently included panel discussions on given topics. These were chaired byNRC or Agreement State officials with panel participants from both groups. Inmore recent years, the ratio of the number of NRC speakers to Agreement State

9 A list of the chairpersons of the OAS is shown in Appendix C.

10 Note that this arrangement preceded the more recent brouhaha overcomplications arising from considerations under the Federal Advisory CommitteeAct (FACA). The recent position of the NRC is that state officials cannotbecome active partners in such working groups or committees. This is an issuethe Agreement States continue to feel needs a more satisfactory resolution.

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speakers has been about two to one, but most of the panels have been chairedby Agreement State officials.

During the early years, AEC staff took notes and prepared internal reportsof the meetings. Since about the mid-1970s, the NRC has used a court report-er. Few, if any, of these reports have been furnished to the AgreementStates.

The AEC normally has invited non-Agreement States that are activelynegotiating an agreement to send one official to these meetings. These rangefrom one to four non-Agreement States each year.

Beginning in 1971, the Agreement States began meeting for a half-dayamongst themselves with no federal officials present. This allowed the statesto discuss issues common amongst themselves, issues relating to AgreementState/NRC relations, and to prepare suggestions and recommendations for NRCconsideration. The closed atmosphere of this meeting allowed for very frankand open discussions. In order to conduct this meeting the Agreement Statesfor several years elected a chairman whose main tasks were to organize anagenda for the meeting, preside over the meeting, and send a letter withrecommendations to NRC, which were normally addressed to the Director, Officeof State Programs.9 Beginning with the 1989 meeting, these letters have beenaddressed to the Chairman of the NRC. The states expect the NRC to reply toeach of their comments, which generally happens, although not always to thesatisfaction of the states.

On occasion, the NRC would consult with the chairman of the OAS on someparticular issue, and sometimes ask for suggestions for persons from AgreementStates who might serve on an ad hoc committee being established by the NRC.10 At the October 1985 meeting, the Agreement States elected both a chairman andchairman-elect. This continued until the October 1991 meeting when theAgreement States established a more formal structure. The OAS established anExecutive Committee composed of a chairperson, past-chairperson and chairper-son-elect with some modest operating guidelines provided to the ExecutiveCommittee. The chairperson was designated as the principal point of contactfor the OAS.

In 1989, the NRC staff requested they be allowed to sit in on the OASmeeting as observers. This was denied, but the NRC made the request again atthe 1991 meeting. At the beginning of the 1991 OAS meeting, the AgreementStates debated the issue. After a vote, it was decided to allow the NRC staffto be present as observers. This practice has continued to date, but thestates reserve the right to close portions of the meeting if deemed appropri-ate. A copy of the agenda for the 1993 annual meeting is shown in Appendix H. One might compare the topics discussed with those shown in Appendix G for the1964 meeting.

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VI. AEC/NRC Officials and Organization

The initial AEC organization charged with developing the Agreement Stateprogram, including negotiation of agreements and post-agreement cooperativework, was the State Relations Branch in the Division of Radiation ProtectionStandards of the AEC's regulatory arm. In 1964, the AEC's Director ofRegulation established the Division of State and Licensee Relations (SLR). The director of the division was Eber Price and the assistant director wasCharles Eason. The division included the State Relations Branch (SRB), theState Agreements Branch (SAB) and two other unrelated branches. When the AECinitiated its licensee fee program in the late 1960's, this function also wasplaced in SLR. The SRB was headed by George W. (Bill) Morgan, and a key staffmember who served many years in that branch was John Vaden (currently ofNevada). The SRB provided developmental assistance to prospective AgreementStates and an extensive training program for state officials. In the earlydays of the program, the SRB and the PHS jointly manned exhibits at variousmeetings that described the program and other aspects related to the use ofsources of ionizing radiation.

The SAB was headed by Ben Harless. This branch actually negotiated theagreements and conducted the post-agreement program of information exchange,technical assistance and program reviews. One major policy change institutedby Price was that the AEC would not take a heavy promotional approach towardobtaining new Agreement States. Rather, the SLR staff would provide extensiveadvice and assistance to any state when the state decided to pursue seriouslyan agreement. Price remained the SLR division director until 1971 and wassucceeded by Lyall Johnson, who served as director until 1972. In the yearsfollowing passage of the National Environmental Policy Act of 1969, the AEC'sregulatory arm underwent a major expansion and reorganization. In 1972, SLRwas abolished and an Agreements and Exports Branch (AEB) was relegated to thelowest organizational level in what was the equivalent of today's Office ofNuclear Material Safety and Safeguards (NMSS) in the NRC. The AEB carried outall state-related functions as well as export licensing.

Gene Blanc, a former Director of AEC's Region V office, was named chief ofthe AEB in 1972. Blanc continued in this position until late 1974, when WayneKerr was named chief of the AEB. Kerr recruited Joel Lubenau, Lloyd Bolling,and Kathleen Schneider, among others, into the state agreements portion of theAEB operation. These three individuals are to this day key officials in theNRC regulatory program.

In June 1976, the NRC reinvented the wheel and created the Office of StatePrograms (OSP) as a staff office reporting to the Executive Director forOperations. The Commission felt that the states' activities were of suchimportance that they should be centralized and not be buried deep in theorganization, and recognized the importance of state relationships in a numberof areas of common interest. The director of OSP was Robert Ryan, who wasrecruited from the U.S. Environmental Protection Agency. OSP consisted ofthree organizational components. Kerr was named Assistant Director for StateAgreements and carried out the functions of the AEB minus export licensing,which was placed in the Office of International Programs. Sheldon Schwartzwas named Assistant Director for State Liaison, which carried out generalliaison activities with state and local governments and their organizations.

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These liaison functions covered aspects related to transportation, power plantlicensing and liaison with the Conference of Radiation Control ProgramDirectors (CRCPD). Harold (Doc) Collins was named Assistant Director forEmergency Preparedness. This unit reviewed states' plans for responding toemergencies at nuclear power plants. It also arranged emergency responsetraining for state and local government staff, primarily the RadiologicalEmergency Response Operations (RERO) course conducted at Las Vegas, Nevada.

The OSP organization remained unchanged until late 1979. In the aftermathof the March 1979 incident at the Three Mile Island nuclear power station atMiddletown, Pennsylvania, many changes were made in the federal government'sresponse planning for emergencies at large nuclear facilities, primarily powerplants. These changes also had significant impact on state and local govern-ments. Messrs. Ryan, Schwartz, Collins and a few others involved in emergencypreparedness were detailed to the Federal Emergency Management Agency (FEMA)for several months to work in this program. The remaining NRC emergencypreparedness functions were placed in the NRC's Office of Inspection andEnforcement (IE).

After serving as acting director for several months, Kerr succeeded Ryanas Director, OSP in September 1980. OSP then had two organizational compo-nents, Assistant Director for State Agreements (ADSA) and Assistant Directorfor State Liaison (ADSL). Kerr recruited Don Nussbaumer from NMSS to fill theADSA slot. Nussbaumer had extensive experience in the NRC's fuel cycle andmaterials licensing program. Schwartz returned briefly to the ADSL position,and when he left, Kerr created a slot titled Assistant Director for State andLicensee Relations (ADSLR). The position was filled with Jerome Saltzman fromthe Office of Nuclear Reactor Regulation. Frank Young headed the sectiondealing with state relations. In addition to liaison functions, the ADSLRalso was assigned the duties of administering NRC's Price-Anderson indemnityprogram, review of licensee financial qualifications and nuclear insuranceprograms.

In 1981, the NRC decided to place a state agreements officer in eachregion. The perceived advantage was to have these officers located geographi-cally closer to the states they served on a daily basis and that they reviewedperiodically. Presumably, they would develop a more in-depth knowledge of thestates in their region. There also was a presumed saving of travel expenses,since the officers were located in the geographic area of the Agreement Statesin that region. State agreement officers were placed in NRC Regions I, II andIV in 1981, in Region V in 1982, and in Region III in 1987.

Kerr retired as Director, OSP in March 1987 and was succeeded by CarltonKammerer, previously Director of NRC's Office of Congressional Affairs. OSPwas renamed the State, Local and Indian Tribe Programs (SLITP), a component ofa new Office of Government and Public Affairs (GPA) reporting to the Commis-sion. GPA was headed by Harold Denton of Three Mile Island fame. Schwartzbecame the Deputy Director of SLITP. In late 1988, Don Nussbaumer retired asADSA and Vandy Miller, a branch chief in NMSS, replaced Nussbaumer.

Miller took another position in the NRC in June 1993, and was replaced onan acting basis by John Surmeier. In the aftermath of the Synar hearing onAug. 2, 1993, Kammerer was replaced as Director of OSP by Richard Bangart,formerly Director of the Division of Low-Level Waste Management and Decommis-sioning in NMSS. Schwartz retired in February 1994. Paul Lohaus, who served

11 NRC Annual Report for 1990, p. 108.

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in management positions in NMSS, and was previously an OSP staff member,became the Deputy Director, OSP. Lohaus had worked for the State of NewYork's coordinating office in the early 1970s.

Various organizational changes of the NRC programs concerning staterelations have been noted above. However, there were other attempts torestructure the functions, some of which failed. These attempts may havereflected a poor understanding of these functions by senior NRC management anda lack of appreciation for their importance, have been used to address someperceived organizational problem, or resulted from some personality differenc-es among officials.

The abolishment of the Division of State and Licensee Relations in 1972appears to have been instituted to address severe personnel shortages as aresult of coping with the National Environmental Policy Act (NEPA) legisla-tion. Since the agreement state program performed some functions similar tothose of NMSS, the branch was located in NMSS. However, the then Director ofRegulation, L. Manning Muntzing, retained an active interest in the AgreementStates. He made opening remarks at the annual joint meetings, and sometimeswas present at the close when the Agreement States made recommendations to theNRC.

When the Office of State Programs (OSP) was established in June 1976, abetter understanding of the importance of state relations in the framework ofthe NRC's total program was reflected. In addition to the state agreementsprogram, states had significant concerns and legitimate roles in emergencypreparedness for the NRC-regulated facilities, high-level waste disposal, low-level waste disposal, transportation of radioactive materials, siting ofnuclear facilities, and granting water quality permits, to name a few. It isnotable that the newly created Nuclear Regulatory Commission had been in placeabout 18 months when the decision to create OSP was made. Further, at leastone of the then sitting Commissioners, Richard Kennedy, had a keen interest inthe issue and was always a strong supporter of the OSP, its activities and itsstaff.

In June 1980, shortly before Kennedy's term expired, a fledgling attemptwas made to abolish OSP and to again relocate the state agreements program inNMSS. It is not clear who instigated the proposal, but Commissioner Kennedywas incensed when he heard of the plan, which had not been sent officially tothe Commission. It appears the proposal was at least partially related to theactions discussed in Section III.B. above concerning Rhode Island. Theincongruity of the Rhode Island situation was shown by an NRC action in 1990. On July 30, 1990, Chairman Kenneth M. Carr sent a letter of commendation tothe Honorable Edward DiPrete, Governor of Rhode Island, acknowledging thestate's outstanding Agreement State Program, sustained over 10 years.11 Thus,the dire predictions about Rhode Island's capability raised by NMSS in 1979were apparently unfounded.

Even after the issue of the abortive reorganization attempt was settled in1980, Commissioner Gilinsky expressed his belief that evaluations of eachAgreement State's capabilities would be improved if a major technical line

12 Personal correspondence from Commissioner Gilinsky to G. Wayne Kerrdated July 17, 1980.

13 The NRC established the SLO program in 1976 based on a recommendationof the National Governors' Association. Initially, the principal purpose wasto have the governor of each state designate a liaison officer to the NRC whocould coordinate several state agency interests and responses. This includedNRC requests for information on issues such as granting state permits fornuclear power plants and other nuclear-related issues. They did not serve asan interface on Agreement State matters. The SLOs also could serve as acontact point for the NRC on generic issues by presumably having sufficientstature to gain access to the governor, if necessary. The NRC began havingperiodic national or regional meetings with the SLOs. The appointees rangedfrom Agreement State program directors to agency heads to policy advisors inthe governors' offices. Due to the lack of new power plant licensing actionsin recent years, the current SLO program is more in the nature of a generalinformation exchange.

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office such as NMSS or IE supervised these activities.12 The irony of thesituation was that the then Director of NMSS (a technical line office) had anon-technical degree. When the states learned of the proposed reorganization,many wrote strongly worded letters to the NRC opposing it. They felt thefunctions of OSP were important enough to have some status in the organiza-tion. These letters came from Agreement State officials, state managementofficials, members of Congress, and from governor-appointed State LiaisonOfficers (SLO).13

Another action occurred in June 1980 when the unofficial reorganizationplan surfaced. Marshall Parrott of Oregon and chairman of CRCPD, Dave Lackerof Texas and past chairman of CRCPD, and Charles Tedford of Georgia andchairman of OAS requested an opportunity to meet with the Commission. Theydid so, and urged the Commission not to downgrade the Office of State Programsin general and not to relocate the state agreements program to NMSS. Thestates felt their needs were better served by having a dedicated NRC staff towhich they could turn for information and assistance. These officials alsostated that they would usually come to talk to the Commission if they hadproblems with the agency's relations with them, but in this case they statedthat things were already operating smoothly. After considering these factors,the abortive plan was not pursued. The strong position and support of thestates influenced the then Executive Director for Operations for NRC, WilliamDircks, but the message was apparently lost on the next EDO, Victor Stello,who tried again to abolish OSP by splitting up its units.

In late 1986, the NRC again proposed to abolish OSP by locating the stateagreements program in NMSS and placing the liaison section in the new Officeof Government and Public Affairs (GPA) under Harold Denton. The states againbecame aware of the plan and wrote numerous letters to NRC opposing the plan. In this case, the NRC plan backfired and the Office of State Programs wasmoved to Denton's new GPA office with the functions intact except that thePrice-Anderson indemnity program, financial reviews and nuclear insuranceprogram were returned to the Office of Nuclear Reactor Regulation. The newGPA office reported to the Commission, so the result was that the Office ofState Programs was elevated to a position above the EDO.

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The last major organizational change occurred in the fall of 1991 whenSLITP was placed under Hugh Thompson, Deputy Executive Director for NuclearMaterials Safety, Safeguards and Operations Support as the Office of StatePrograms. The stated purpose of this move was to locate the program organiza-tionally closer to NMSS who carried out similar functions for its licensees asdid the Agreement States for their licensees. Of course, the same argumentdid not prevail for some of the state liaison activities, which frequentlydealt with NRC offices other than NMSS. Another result was the removal of anominal reporting relation of the Directors of Public Affairs and Congressio-nal Affairs to Denton as head of GPA. This series of actions left Denton asmanaging only the Office of International Programs.

VII. Active Phase of Organization of Agreement States

The 1989 All Agreement States Meeting was held Oct. 11 - 13 in OverlandPark, Kansas. The tone for this meeting started to develop at the 1988meeting. The states had not received a response to their letter to the NRCfollowing the 1987 all Agreement States Meeting before the 1988 meeting began. It was not until six weeks (Nov. 15, 1988) after the 1988 meeting that aresponse from the SLITP for the 1987 meeting was mailed to Donald Hughes,chairman of the Agreement States Committee. A quick response by the SLITP wasmade to the written comments made by the states at the 1988 meeting. However,of the seven comments, the response to six of these followed the pattern, "wewill forward your concerns to the appropriate NRC staff and/or we will keepyou advised." Because the states had not been kept advised, the agenda forthe "States Only Meeting" prepared in advance of the 1989 meeting included adiscussion topic entitled "1988 All Agreement States Comments with NRCResponses, Discussion of Unresolved/Ongoing Items." As a result of thediscussion, the Agreement States requested in their 1989 letter updates or thecurrent status on six of the seven items raised in 1988.

The Director of the SLITP opened the technical program with a talk titled"The Agreement States Program's Accomplishments and Challenges." This presen-tation was serious and low-key. In presenting the accomplishments, the toneof the presentation emphasized failures by drawing attention to the 36 stateprogram reviews during the seven-year period of 1981 through 1988 in which theprograms were found to be neither compatible nor adequate. The delivery de-emphasized the 127 reviews during the same time period when the states'programs were found adequate, including the 97 reviews when findings ofadequacy and compatibility were issued. For those states where a finding ofcompatibility was withheld, the predominate reason was failure to adopt NRCrules within three years. Where findings of adequacy were withheld, thepredominate reasons were inspection backlogs and lack of inspector adequacy.

In presenting the challenges, the periodic state program reviews wouldemphasize compatibility. To help address the problems of adequacy, the Officeof State Programs would seek increased budget for training and use lessexpensive training facilities to maximize the availability of training forstate personnel. The speaker then returned to the compatibility issue. Inhindsight, what was probably an attempt to offer assistance to State ProgramDirectors experiencing difficulty in promulgating rules, the speaker statedthat the NRC was willing to talk to Program Directors, Office Directors,

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Commissioners or the Governor to address compatibility issues. The messagewas received almost, if not universally, as a threat by the attendees. Thespeaker had misjudged his audience.

The next topic on the agenda was titled "Training and Operations Discus-sions." Two presentations were made concerning training and operations. Thetone of the remarks by the first presenter can be conveyed best by quotingfrom Greta Dicus' letter to Chairman Carr dated Nov. 16, 1989. "We also takespecial note this year of the keynote address by Dr. John Montgomery, DeputyAdministrator, NRC Region IV. His most positive remarks about the partnershiptype relationship which exist between the states and the U.S. NRC are consis-tent with our concept of how we must relate with each other." The nextpresentation under this agenda item was by the Assistant Director for StateAgreements Program and focused on operational items. The item that receivedeveryone's attention was a proposal for state recognition. Those states thatmet the "Performance Indicators for State Recognition" or accomplished someother notable action would receive a "GOLD STAR" award and see the "inspector"less often. Note: INSPECTOR, not program reviewer or agreement statesofficer. Needless to say, this proposal received many negative comments fromthe Agreement State representatives.

Before lunch on the opening day of the 1989 all Agreement States Meeting,the stage had been set for the future working relationship between theAgreement States and the NRC. The states received a threat, then a talk thatthey could endorse and then a condescending proposal for recognition. Confusion reigned. The states arrived at the meeting concerned that the NRCwas not responsive to states' needs and issues, and before lunch were present-ed with proof positive that their concerns were not unfounded. This onlyadded to the states' concerns about their relations with the NRC, prompted byindividual remarks attributed to senior NRC staff. Such comments as "Don'tworry about the Agreement States, they'll do what we tell them." and "This isthe compatibility regulation of the year." were not conducive to a goodrelationship.

During the states-only meeting, the members responded to their concernabout the lack of responsiveness to their letters and the "stick and carrot"message received during the opening session by directing the chairperson toaddress all future correspondence to the Chairman of the Commission, notdirectly to the Director of the Office of State Programs. The Nov. 16, 1989letter to Chairman Carr marked the first correspondence directly to theChairman from the Organization of Agreement States.

Frequently, NRC invited U.S. Air Force and U.S. Navy representatives toattend the Agreement State meetings. The NRC had requested to attend the OASstates-only meeting in 1989. The OAS declined this request, but did allowrepresentatives of the Air Force and Navy to attend as observers. Even thoughthese persons represented NRC broad licensees, one of them remarked to an adhoc committee member that their problems with the NRC were not unlike thosethat the Agreement States experienced.

Although some progress had been made by the October 1990 meeting, it wasnot deemed totally sufficient by the Agreement States. Chairperson Dicus'letter of Dec. 7, 1990 to NRC Chairman Carr noted that a separate letter oncompatibility would be forthcoming. Such a letter was sent by the next OASChairman, Tom Hill, on Jan. 24, 1991, presenting some detailed preliminary

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thoughts on the compatibility issue and announcing the formation of an OASTask Force on Compatibility. This action generated sufficient attention bythe NRC's own interoffice compatibility task force to request a meeting with the OAS task force. Hill submitted the report of the task force to ChairmanCarr by letter dated March 13, 1991. The actions of the Agreement States in1989, 1990 and 1991 placed the issue of compatibility squarely on the NRC'splate. Absent those actions, the NRC would not likely ever have recognizedthe deep concerns of the Agreement States. However, one NRC manager expressedthe view that Dicus' letters were not helpful! It also should be noted thatthe OAS Task Force on Compatibility was the first formal group ever estab-lished by the OAS to set forth consolidated views on a subject.

At the Commission's request, the Executive Committee met with the Commis-sion in the summer of 1991. The OAS representatives generally discussed theissue of compatibility and other aspects of OAS/NRC mutual relations. TheExecutive Committee, together with representatives of four other AgreementStates, met with the Commission in January 1993. This discussion focusedprimarily on medical issues, since this meeting followed shortly after thearticles that appeared in the Cleveland Plain Dealer in December 1992. Thechairman of the OAS met with the Commission on Feb. 8, 1994, in what is nowplanned to be an annual briefing.

The chairman of the OAS represented the Executive Committee of the OAS andthe Executive Board of the Conference of Radiation Control Program Directorsat the Aug. 2, 1993 hearing on the Agreement State program convened by theSubcommittee on Environment, Energy and Natural Resources of the HouseCommittee on Government Operations. This hearing was at least in part aresult of the GAO report on the program that was released in April 1993.

It appears the OAS will continue to be actively involved in developingissues concerning the regulation of agreement materials. The chairperson has,at various times, been asked to speak at such meetings as those of theAmerican Society for Non-Destructive Testing and to participate in the NRC'sresidual radioactivity rulemaking public meetings.

VIII. Perspectives on Selected Technical Issues

The ad hoc committee felt there were a number of areas regulated by theNRC and Agreement States that have been of concern for many years. Mostcontinue to this day to be frequent topics of discussion among the NRC and theAgreement States, and with their respective licensees in many cases. There-fore, it was deemed appropriate to include some historical and regulatoryperspective on six technical subjects.

A. Regulation of Medical Uses of Radioactive Material

The regulation of medical uses of radioactive material in the 1960s, whenthe Agreement State program began, was drastically different than the programin 1994. This section will focus heavily on the activities of the AgreementStates (and sometimes with AEC/NRC input) in this area, particularly as theprogram has developed through the CRCPD's Committees on Suggested StateRegulations For Control of Radiation (SSRCR).

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The AEC/NRC regulated these uses from 1946 forward. At one time oranother, the AEC program covered nearly every aspect of nuclear medicine,including efficacy determinations as well as radiation safety considerations. These broad aspects, particularly efficacy determinations, occurred between1962 and 1975. During those years, the FDA exempted radiopharmaceuticalsregulated by the AEC and Agreement States from the FDA's requirements for newdrugs.

In 1975, the FDA withdrew that exemption for radiopharmaceuticals and theNRC withdrew from regulating drug safety and efficacy. The 1976 MedicalDevice Amendments to the Food, Drug and Cosmetic Act extended the FDA'sauthority to medical devices containing radioactive material. Prior to theFDA withdrawal, however, the AEC and Agreement States evaluated proposals forinvestigational new drugs with the assistance of their respective MedicalAdvisory Committees. Such investigative and research proposals were supportedby protocols describing the proposed studies that were evaluated by thesecommittees. Physician's training and experience also were evaluated by thecommittees. When enough data was accumulated to establish the efficacy of anew drug, the AEC Advisory Committee approved it for routine use, and thislist of approved uses was furnished to the Agreement States for their guidance(known as the routine use list).

On Feb. 9, 1979, the NRC published a statement of general policy on theregulation of medical uses of radioisotopes (44 FR 8242). It established theNRC's role of principally regulating radiation safety aspects, minimization ofintrusion into judgements affecting the practice of medicine, and regulatingthe safety of patients only in limited circumstances. This statement ofpolicy remains in place today; however, the NRC is undertaking a major reviewof the regulation of medical uses in the aftermath of the serious incident atthe Indiana Regional Cancer Center in Indiana, Pennsylvania in November 1992,a series of articles in the Cleveland Plain Dealer in late 1992, and a hearingby the Senate Committee on Governmental Affairs in May 1993. A significantstep in this review is a two-year study being performed by the NationalAcademy of Sciences covering such issues as risk, policy guidance and institu-tional relations.

Earliest records relating to the development of SSRCR on medical usereference a meeting held in Kansas City in May 1977 in which the new Part "L"Committee, chaired by Gerald Allen of Kansas, was to look at the need fordrafting regulations for nuclear medicine. The task force reviewed notes of arecent meeting of the Part "K" Task Force (on radiopharmaceuticals) and apublic hearing held by the NRC on May 6, 1977 in Silver Spring, Maryland. Most of the time was spent reviewing existing regulations such as the MedicalDevice Amendments of 1976, those of the FDA and the NRC, and the JointCommission on Accreditation of Hospitals. Allen was to make a report onbehalf of the committee at the annual CRCPD meeting in Seattle. Members ofthe committee were Donald Hamilton, BRH; Goldie Watkins, New York; SteveCollins, then of Louisiana; and Gerald Allen, Kansas.

In March 1978 another meeting of the committee was held in Kansas City. In addition to those listed above, Dan Hightower, D.V.M., and Gerald Johnson,D.V.M., were in attendance, and the discussion centered on the use of radio-pharmaceuticals in veterinary medicine. The committee concluded that the "useof radiopharmaceuticals in veterinary medicine was not well enough understood

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to deal with effectively." The committee decided to produce a draft ofPart L, nuclear medicine, for the SSRCRs.

The committee met in Harrisburg, Pennsylvania at the 1978 annual meetingof the CRCPD. At this meeting Collins provided a first draft to whichWatkins, Hamilton, Collins and Allen made minor suggestions and created a newdraft. At this meeting Watkins asked to be removed from the committee so thatshe could concentrate on newly added responsibilities as Chairperson of TaskForce II, "Public Health Impact of Nuclear Medicine." In 1979 a revised draftof Part L with accompanying rationale was sent to a selected group of indiv-iduals for preliminary review and comment.

While this work was being done by the CRCPD committee, a move was underwayby the NRC to incorporate the vast number of license conditions and regulatoryguide requirements placed on nuclear medicine licenses into the regulations. The thought was that if the conditions and guides had the effect of beingrules, they should be codified. In the early 1980s, the NRC proposed torevise 10 CFR 35. With the understanding that the NRC's revision of Part 35would substantially change existing rules for nuclear medicine, the work ofthe Part L committee was put on hold pending further action by the NRC.

The states had expressed a desire to be a party to the early rulemakingprocess and were invited by the NRC to be early participants. At the 1984meeting of the Agreement States, an ad hoc committee was appointed to reviewthe proposed changes to Part 35. The committee was chaired by Mary Lou Blazekof Oregon with Carol Connell of Georgia and Kirk Whatley of Alabama (newChairman of the CRCPD Part L committee) as members.

The CRCPD also appointed an ad hoc committee to review the changes toPart 35. This committee was chaired by Blazek and included the other membersof the Agreement States committee. This committee was not the same as thePart L committee.

At the 1984 Agreement State meeting, the state representatives discussedthe possibility of writing nuclear medicine rules for states and not waitingon the NRC. However, no request was made to the Part L committee to proceed. The chairman of the Part L committee requested clarification from the CRCPDChairman, Chuck Tedford of Arizona, and was advised to proceed with continuingthe development of nuclear medicine rules for the SSRCRs.

With its charge clarified, the Part L committee met in Milwaukee duringthe annual CRCPD meeting in May 1985 to discuss the charge to the committeeand to make plans for writing nuclear medicine rules for the SSRCRs. Mary LouBlazek, Paul Eastvold of Illinois, Steve Collins, Kathy Schneider (NRC,standing in for Lloyd Bolling of the NRC), and Kirk Whatley attended thismeeting. The committee agreed to use the latest revision to 10 CFR 35 as abasis from which to proceed. Kathy Schneider volunteered to put the NRCversion into the SSRCR standard format for review by the committee. ThePart L committee was invited to an NRC briefing on the plans for the revisionto 10 CFR 35. The proposed changes were drastically different from what theState representatives had envisioned.

A Federal Register Notice stated that since the field of nuclear medicinehad become so stable and because few significant changes were expected to take

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place over several years, basically all regulatory control should be removed. The NRC proposed that all nuclear medicine should be generally licensed. The

concept was that a nuclear medicine applicant would use a check-off formstating that requirements were understood and that the applicant met require-ments for the use of radioactive material. The applicant also was to use acheck-off sheet as proof of training, both for diagnostic and therapeuticuses.

Instead of experienced NRC license reviewers performing reviews ofapplications, the applications would be checked by clerical staff to assurethat all items of the forms had been addressed. If the forms were completethe clerical staff would type out the "standard license" on the spot. Noprocedures were to be submitted. No documentation of training was to besubmitted. No review was to be made. Such a system would avoid delays inprocessing applications and the time in which a license could be written,which at times was substantial since the NRC's medical licensing staffconsisted of two individuals. The members of the Part L committee and the adhoc committee members expressed their concern and disagreement with thisradical departure from current licensing practices. Many representatives ofthe states expressed disagreement with the NRC's proposed changes.

The NRC held a hearing on the subject of the nuclear medicine rule changesand invited representatives of the states to offer comments before theCommission. William Spell of Louisiana addressed the concerns and objectionsof the states.

One needs to understand the intensity of the debate that occurred on thismatter. Many states were strongly opposed to the concept and openly expressedthose concerns. Many of the NRC employees also were extremely opposed to theconcept. In fact, the NRC's entire nuclear medicine licensing staff tookannual leave to appear before the Commission in opposition to the concept. Over a period of time, and in face of the opposition, a new approach tolicensing nuclear medicine was developed by the NRC.

The NRC's next proposal was to continue basically the licensing process asit had been done in the past except that the applicant would not have tosubmit any written radiation safety procedures for review with the applica-tion. The idea was that the applicant was capable of, and would in fact,develop written procedures and that the procedures would be adequate. Insteadof reviewing the procedures during the licensing review, the procedures wouldbe reviewed during inspections. The licensee also would have the flexibilityto change the procedures without review or concurrence by the NRC prior toimplementing the changes.

Again, many states expressed disagreement and concern over this newconcept. Concern was again expressed by the NRC staff. The NRC's Region IIIAdministrator wrote on March 11, 1986, "we do wish to point out that yourstatement, ‘with the exception of the Agreement States, the flexibilityprovision was widely endorsed’, is not totally accurate. We still prefer thatthe regulation not permit medical programs the freedom of modifying theirprocedures, since some of them may not have the ability to perform therequired internal review and approval process."

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The NRC's Region I Administrator expressed concern over another change bystating, "We believe that the final revision to 10 CFR 35 represents a majorpolicy change regarding the level of supervision to be exercised by theauthorized user. We are concerned that the lack of specificity regarding theexpected duties of the supervisory physician makes enforcement of the autho-rized user condition meaningless if not impossible."

Reverting back in time for a moment, the phrase, "radioactive materialshall be used by (named physician)", had been interpreted by NRC, in writing,to mean the following:

The licensed nuclear medicine physician (named on the license) must:

1. Select each patient to receive radioactive material by eitherexamining the patient himself/herself; reviewing the patient'schart; or consulting with the referring physician,

2. Prescribe the isotope and dose to be administered and

3. Interpret the results of the study.

These responsibilities could not be delegated to other physicians who were notlicensed to practice nuclear medicine. This concept was changed to permit anyphysician to order diagnostic nuclear medicine procedures on patients and toenable any physician to interpret the results of the studies. Questions wereraised regarding the necessity of diagnostic nuclear medicine trainingrequirements if any physician (with no nuclear medicine training) could selectpatients and interpret results of studies. Despite several letters ofconcern, Part 35 was published without specifically requiring the authorizeduser to interpret the results of the study.

This led to even greater confusion regarding who is allowed to interpretresults. A March 30, 1990 letter to all Agreement States (SP-90-63) statedthat "The interpretation of patient images or data is considered to be withinthe practice of medicine and outside the scope of NRC regulations." Almostexactly one year later, a March 1, 1991 letter to all Agreement States(SP-91-28) stated that "it is the licensee's responsibility to ensure that atleast one interpretation of nuclear medicine scans is performed by an autho-rized user or a physician under the supervision of an authorized user" andfailure to do so might result in a violation of 10 CFR 35.13(a) for failure tosupervise and 10 CFR 35.13(b) for use of radioactive material by an unautho-rized individual.

The concept of revising 10 CFR 35 was supported by the Agreement Statesand the NRC staff from the standpoint of incorporating license conditions andregulatory guides into the rules. Differences of opinion that created heatedopposition were raised over proposed significant changes to the licensingprocess that had evolved over the years.

During the development of revisions to 10 CFR 35, the CRCPD Part Lcommittee expanded its efforts in reviewing and commenting on the proposedchanges and attempting to keep the Agreement States apprised of significantnew proposals and problems. The membership of the committee changed as Blazekand Connell changed jobs. Paul Eastvold and Terry Frazee, Washington, were

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added as members. Steve Collins (now from Illinois) also provided muchassistance to the committee. The work and effort of Lloyd Bolling of the NRCwas especially helpful.

The NRC's newly revised 10 CFR 35 was published in the Federal Register onThursday, Oct. 16, 1986, with an effective date of April 1, 1987. The finalversion, although not totally endorsed by the Part L committee, was one thatsignificantly improved the old Part 35 and could be used by the states withminor revisions.

In early 1987 the Executive Board of the Conference combined the SSRCRCommittees for Part "G" (Use of Sealed Radioactive Sources in the HealingArts) and Part "L" (Nuclear Medicine). The resulting SSRCR "G/L" Committeeprepared a "new" Part "G" based on the final 10 CFR 35 rule. The new Part "G"was sent to the Technical Review Committee of the Conference, which requiredmany style changes. Due to the lack of a "style manual" for the SSRCRs, Part"G" had been drafted using one of several styles found in the SSRCR at thetime.

In March 1988 the final draft Part "G" was sent to the states for review,and in August 1989 was sent for federal concurrence. Additional changes wererequired to gain NRC concurrence, but the new Part "G" was ready in early 1990for Executive Board approval and was issued in the 8th Edition of the SSRCR.

In the meantime, the SSRCR "G/L" Committee became known as the SSRGroup 6, "Use of Radioactive Material in the Healing Arts" (SR-6). In January1990, Terry Frazee assumed the role of chair of SR-6. It was also at thistime that the first non-state regulator became an advisor to the committee. A number of the new associate members of CRCPD became advisors in the ensuingyears, bringing with them the perspective of the regulated community. Theirinsight into such issues as the ACNP/SNM petition, the NRC basic qualityassurance program, and use of Positron Emission Tomography (PET) helped moveSR-6 toward favoring less prescriptive regulation.

The NRC proposed changes to Part 35 that included misadministrationreporting and a requirement that licensees develop and submit a QualityManagement Plan (QMP). The purpose of the QMP was to reduce the number oferrors in administration of radiopharmaceuticals, although medical profession-als argued that the rate of error was already quite low, considering thenumber of administrations performed each year. A QMP development timeline isshown in Table 1.

The SR-6 committee generally believed that the NRC's basic qualityassurance program would most likely fail to attain the NRC's goal of prevent-ing errors, since most misadministrations seemed to be caused by "human error"rather than a system problem. However, members of SR-6 were actively involvedin the NRC's series of workshops involving Agreement States and the public in1990 and 1991 from which emerged the renamed Quality Management program. Atthe end of the Quality Management Workshop in San Mateo, California inFebruary 1991, the Agreement State representatives, including several SR-6members, advised NRC: 1) to republish the quality management rule because ofthe substantial changes that had occurred since the public and regulatedcommunity had last seen it; 2) to not make the quality management rule amatter of compatibility since it dealt heavily with the practice of medicine,a state's right to regulate; and 3) if compatibility had to be addressed, to

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place the rule in Division 3 to allow the states to develop, or in some casesto continue using, alternative paths to achieve the same goal.

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Table 1. Quality Management Program Timeline

Dec. 1989 Draft Regulatory Guide, "Basic Quality Assurance Programfor Medical Use."

Jan. 16, 1990 Proposed rule published in Federal Register.

Jan. 1990 Letters sent from Brookhaven National Laboratory to licens-ees requesting participation in Pilot Program.

March 14, 1990 NRC held public workshop.

July 23, 1990 NRC workshop with ACNP and SNM to compare QMP and JCAHOstandards.

Dec. 18-19, 1990 NRC held public workshop (Irving, TX).

Feb. 7-8, 1991 NRC held public workshop (San Mateo, CA).

July 25, 1991 Final rule published in Federal Register, with an effectivedate of January 27, 1992.

Oct. 19, 1991 Reg. Guide 8.33 "Quality Management Program"

Jan. 25, 1992 Letter from James B. MacRae, Jr., OMB's Acting Administra-tor for the Office of Information and Regulatory Affairs toJames Taylor, NRC's EDO, questioning NRC's need for the QMrule and its burden on licensees.

Jan. 27, 1992 QMP rule effective.

Feb. 5, 1992 ACNP and SNM filed a brief in their lawsuit against NRCwhich challenges the medical quality management rule.

May 12, 1992 Oral arguments in lawsuit.

June 26, 1992 OMB informed NRC that OMB was disapproving the informationcollection request for the QMP rule. This meant NRC couldnot enforce the information collection requirements of therule (including reporting of misadministrations) after thisdate. However, licensees would still be required to col-lect and report for the period of time Jan. 27 - June 26,1992.

Aug. 14, 1992 NRC Commissioners override OMB. This keeps the rule effec-tive for three years. AAS letter (SP-92-136) indicatesthat "if the Commission finds this rule, in whole or inpart, to be overly burdensome or ineffective, it willconsider modifying or deleting portions of the rule."

Jan. 21, 1994 Compatibility deadline (as per SP-92-136).

Jan. 25, 1995 Compatibility deadline (as per Fed. Reg. Vol. 56, No. 143,p. 34118).

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The SR-6 committee met in May 1991 at the Wichita, Kansas annual meetingof the CRCPD. Major topics of discussion were NRC's quality management ruleand changes in the misadministration rule, the use of PET and the need tocoordinate with SR-3 in evaluating the regulation of PET. Because of a shortcomment period for the NRC's proposed changes to the misadministration rule,the committee prepared comments and submitted them on CRCPD letterhead whileat the annual meeting. This led to the development of committee letterheadfor all committees and a procedure for gaining approval of the Executive Boardfor any use of the CRCPD letterhead.

In September 1991, SR-6 held a joint meeting with SR-3 in Tampa, Florida. The meeting was developed around a visit to an operating PET facility and apublic hearing designed to educate committee members on all aspects of PET. SR-6 members gained a greater appreciation for the similarities to convention-al nuclear medicine, and appropriate changes to Part "G" were drafted. As aside note, interest on the part of the regulated community was kindled in theCRCPD which resulted in many new associate members.

The next meeting of SR-6 was in Orlando, Florida in May 1992 when morechanges to Part "G" were proposed. The patient release criteria, dosecalibrator requirements, "moly breakthrough" frequency and other requirementswere modified to reflect more of a performance (and less of a prescriptive)requirement. Also, the training and experience requirements for authorizedusers were evaluated in light of the states' role in regulating the practiceof medicine. It was felt that the radiation control programs should regulatethe handling of radioactive material and leave judgements concerning who isqualified to select patients and interpret results to the states' board ofmedicine and the professional associations. The committee also discussed theemerging issue of the NRC regulation of nuclear pharmacies. In July 1992several members of SR-6 attended the NRC's Workshop on Medical Issues inAtlanta, Georgia, where nuclear pharmacy, doses to the public, and patientrelease criteria were discussed.

The latest draft revision of Part "G", covering PET, authorized userqualifications, the misadministration rule change and quality management wassent for peer review in October 1992. The Regulation Oversight Committee(ROC) received the updated version in April 1993. Delays in the ROC reviewhelped prompt a change to the SSRCR review process. At one point the qualitymanagement rule was removed from the proposed revision because of the beliefthat a lawsuit against it and political pressure would negate the rule, andthe committee did not want to put something in place only to have to removeit. In early 1994, the Executive Board specifically asked for the qualitymanagement rule to be included so that model regulations would be in place bythe NRC's compatibility deadline. The proposed revision of Part "G" was sentto all radiation control programs in April 1994.

In recent years, SR-6 has been of the opinion that some NRC requirementsintrude upon the practice of medicine, and this usurps the states' right andprimary responsibility to regulate the public health and welfare. Thecommittee believes the concept behind many of these requirements may have somevalidity, but the actual rules tend to be too prescriptive. In effect,prescriptive rules remove a sense of responsibility from the regulated community as well as restrict innovation. The committee believes perfor-mance-based rules make the licensee think through procedures and actions, and

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makes both licensee and regulator operate on health physics rather than"bureaucratic" principles.

It appears that issues relating to medical uses will continue to requiresignificant attention for the foreseeable future, particularly in view ofactions being taken by the NRC as discussed previously in this section.

In light of the 1992 and 1993 events, one might consider how the NRC wouldview the medical situation today if the earlier proposal to generally licensemost medical uses had gone into effect. It appears the work of the states andsome NRC staff had a salutary effect on this process.

B. Regulation of Industrial Radiography

Industrial radiography, a subset of non-destructive testing (NDT), hasbeen performed for many years. In fact, early experimenters with x-rayradiographed persons' hands and other body parts and could arguably have beenperforming non-destructive testing.

Industrial radiography utilizing x-ray and sealed radium sources has beenperformed since the 1930s, but sealed sources of by-product material have beenused commercially since shortly after passage of the Atomic Energy Act of1954, when the AEC released by-product radionuclides for civilian use. Earlymethods of use would be considered somewhat primitive by today's standards. The "fishpole" technique is probably as rare today as some of the flyingreptiles of days past. However, the persons who perform these tasks underless than ideal conditions have not changed drastically.

This industry has experienced a significant number of serious overexpo-sures, frequently to the extremities of the individual doing the work. Thefirst industrial radiography training manuals were produced in the late 1950sby a professor at Louisiana State University under contract with the AEC. This manual covered not only radiation safety but also the methods of perform-ing industrial radiography. Many state and federal personnel have beentrained utilizing these manuals. In 1982, the NRC produced a safety manualfor gamma radiography, NUREG/BR-0024, which contained graphic pictures of theeffects of large radiation doses to the fingers and hands and other parts ofthe body. This book is widely used in training courses around the nation andhelps document what has happened, as well as to demonstrate what can happen ifsafety procedures are not followed. It is significant to note that consider-able expertise exists in the states to evaluate these types of exposure,especially in the major oil and gas producing states where radiography iswidely utilized. In addition, the Oak Ridge REAC/TS facility is available toassist in assessing the medical impacts to accident victims.

Horror stories of unsafe practices and attempts (usually successful) tothwart regulations abound. However, regulators persisted in attempting tomake the practice safer, and several innovative methods and modifications toequipment to make devices "fail-safe" have come about over the years. Some ofthe regulators' experience with industrial radiography have spilled over intoother areas and can be readily identified, e.g., certification of industrialradiographers, oil and gas well-logging regulations, and National VoluntaryLaboratory Accreditation Program (NVLAP) approval for personnel dosimetry. These initiatives had their origins, at least in part, with the AgreementStates, sometimes with the support of federal regulators.

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In addition to relatively few fixed location devices around the countryfor industrial radiography, most devices are self-contained and portable,leading to problems unique to this type of NDT. Large quantities of verypenetrating sources of radiation are generally used in relatively lightweight,shielded devices. The shielding itself has improved over the years, changingfrom lead shielding to depleted uranium shielding. This allowed more porta-bility of devices containing radiation sources with higher activities. Moresource strength equated to shorter exposure time, which equated to increasedproduction and (possibly) greater profits. Hence, the pressure to do the jobquickly.

Of note in this regard is the variety of working conditions in which mostindustrial radiography is practiced, from the swamps of south Louisiana andTexas and backwoods in other locations, to offshore oil and gas explorationplatforms and so-called "lay barges" in the Gulf of Mexico where pipelines arebeing placed on the floor of the Gulf. At the height of oil and gas explora-tion, radiographers were often required to work long hours in very unfavorableconditions consisting of bad weather, mud, and cold in the wintertime. Offshore, problems of close working quarters, high winds, choppy seas, andtransfer from one location to another by personnel baskets or knotted ropesoccasionally resulted in mishaps, including the accidental loss of equipmentinto deep water with little hope of being retrieved. In addition, in theearly days, because of labor-management disputes, equipment was deliberatelythrown overboard. Fortunately, this usually resulted in little or no dangerto anyone, now or in the future.

Working conditions on lay barges, where both x-ray and sealed sourceradiography are performed, were a bit better as far as creature comforts wereconcerned, but the close quarters and proximity of sleeping quarters to theradiography stations raised questions of potential excessive exposure topersonnel. In the late 1960s to early 1970s, Louisiana conducted a study ofseveral lay barges and made recommendations regarding the addition of shield-ing to increase the protection of workers. In addition, this pointed up theneed for close coordination in a program for the two modalities of NDT whichare used.

Over the years, efforts to improve the safety of radiographic operationshave revolved around safer devices, better training, adherence to regulations,and insistence on the proper use of survey meters. Virtually every investiga-tion of an industrial radiography incident has led to the inescapable conclu-sion that if an operable survey meter had been properly used, there would havebeen no accidental over-exposure.

Since it was obvious that without more extensive enforcement, proper useof survey meters by everyone was not going to be accomplished in the regula-tors' lifetimes, efforts to improve the safety of radiography also includedimprovements in personnel training and the design of so-called "fail-safe"devices. Whether or not such a device can ever be designed is a matter onlytime can tell. No true fail-safe equipment exists today. The proper use ofthe survey meter remains the most reliable device. It may be that the qualityof radiographic personnel is slowly improving to the point where accidentswill be reduced significantly.

In the beginning, when AEC licenses were converted to agreement statelicenses, it became apparent that there were too many in-house training

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courses, especially in smaller companies. Some states rescinded the authori-zation and required observation by state inspectors of those which werecontinued.

Regarding personnel improvements, Louisiana noticed that most of theradiation accidents which occurred at temporary jobsites in industrialradiography involved persons who were not trained to be radiographers but whowere either "assistant radiographers" or "helpers," the latter having evenless training than assistant radiographers. In 1980, Louisiana began torequire that two radiographers be present at a temporary jobsite and that onlyradiographers with several years of experience and a good safety record beallowed to train others to become radiographers. This helped to assure thatonly fully trained persons actually made radiographic exposures at temporaryjobsites. A requirement for two qualified workers at temporary jobsites iscurrently proposed by the NRC for the first time. In addition, trainingcourses were monitored by the state's regulators, and only certain individualswho demonstrated competence were allowed to train others. These were includedas license conditions and formalized in regulations. Some states havefollowed suit, and a number of others are considering it. Additional trainingfor radiographer assistants is now included in the NRC's proposed rules.

Improvements in survey meters and personnel monitoring have also followed. Survey meters have become more rugged and more accurate, as well as smaller,and they may now include alarms. Personnel monitoring is almost exclusivelyof the thermoluminescent variety instead of the early film badges.

One problem observed by the states was that one never knew if the exposurereported by the personnel dosimetry supplier was accurate. In fact, twobadges from different companies, worn in the same location on several radio-graphers in Louisiana, were observed to differ in exposure by as much as anorder of magnitude! Other states, including Montana (a non-Agreement State),had similar concerns. This finding was reported at a workshop at an annualmeeting of the Conference of Radiation Control Program Directors in the early1970s and a task force was formed to study the problem and make recommenda-tions. The ultimate outcome was the NVLAP certification program many yearslater and ultimate adoption of regulations requiring the use of NVLAP-certi-fied suppliers.

Another spin-off of industrial radiography which was initiated by thestates was the development of regulations for the well-logging industry. Inthe mid-1960s, Louisiana worked out abandonment procedures for well-loggingsources lodged down-hole. This included instructions for sealing the sourcein place, placarding the wellhead, and notifying the state oil and gasregulatory agency.

In addition, NRC and the states sought to regulate well-logging much thesame as industrial radiography. With the seemingly bad reputation of indus-trial radiography haunting the well-logging industry, they felt that regula-tions pertinent to their industry were needed. The states agreed, and repre-sentatives from Texas and Louisiana met in Austin. They took those parts ofthe industrial radiography regulations which were felt to be generic enough towarrant retention, added some regulations which were specific to the well-logging industry, and presented the package to the industry. After a year ortwo of discussion with several state representatives, several federal agen-cies, and industry representatives, the regulations became part of the

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Suggested State Regulations for the Control of Radiation. Later, the NRCadopted most of these regulations with a few minor changes.

In the late 1960s, Louisiana attempted to gain support for the estab-lishment of a testing program for industrial radiographers by proposing such aprogram at an Agreement States meeting. The concepts advanced includedindividual responsibility and regulation of radiographers, a nationwideregistry of qualified radiographers, and a method of verifying training ofsuch individuals. This did not materialize until many years later. Again, inthe mid-1970s, the Louisiana program took a close look at the regulations forindustrial radiography to evaluate the need for change. Meetings betweenTexas and Louisiana were held to discuss possible changes to the radiographyregulations. In the late 1970s, Louisiana promulgated regulations which,among other things, removed the assistant radiographer classification,required two-man crews at temporary jobsites, and gave the program theauthority to begin testing radiographers. Small companies that wanted toprovide in-house training were authorized by a license condition in which aspecific instructor was named, and if that instructor left the company, theauthorization was no longer valid. A representative of Louisiana's programattended the training courses to evaluate the training program before issuingan amendment to the license.

The Louisiana program began testing radiographers on a limited basis in1980 but soon learned that it was difficult to develop an adequate test andbegan to encourage the NRC to help in this area. In the early 1980s, the NRCprovided funds to the State of Texas to develop a test which could be used byother states.

The idea of nationwide testing of industrial radiographers did not gainwidespread support until the 1980s, when the state of Texas developed anextensive bank of test questions to administer to prospective industrialradiographers. The effort received support and funding from the NRC. Later,NRC expanded this third-party independent testing to a certification concept. Since the state of Texas wanted to ensure that the test was not compromised byhaving copies getting out of their control, the Conference of RadiationControl Program Directors, Inc., now brokers the test to other states for thestate of Texas. It has gained widespread support as a mechanism to assureadequate formal safety training in the industry. Prior to this time, the onlynationwide testing program was administered by the American Society for Non-Destructive Testing (ASNT). This resulted in confusion, since an individualhad to be a "radiographer" before he or she could apply for certification byASNT. States deemed it inadequate for their needs, since the ASNT Level I,II, and III certifications focused on competency to do the job, not radiationsafety. Now, ASNT offers the Texas examination in their safety certificationprograms.

In addition to changes in regulations, the Louisiana program made indus-trial radiography field inspections the number one priority and began inspect-ing radiography companies several times a year in the field, in addition to anannual office inspection. In fact, an effort was made to inspect everycompany once a quarter and every field crew at least once a year. This typeof concentrated effort is difficult to sustain. In addition, Agreement Statepersonnel, most notably from Louisiana and Texas, have participated in manyindustry and NRC-sponsored safety seminars and training courses.

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Louisiana began tracking reported overexposures in the 1970s but did notkeep a computerized database until 1990. Other states may be doing the same,but the experience in Louisiana has shown a steady and significant decrease inoverexposures in industrial radiography. Reported overexposures in Louisianahave declined from 17 in 1990 to 11 in 1993. Equipment has not changedsignificantly during the period (e.g., no alarming rate meters, automaticlocking devices, etc.).

The apparent improvement in safety is due, in part, to: clients havingmore concern for quality in every area (including safety) since qualityproduces more acceptable results; greater concern on the part of managers andfirms that the job be done right; client companies insisting that radiograph-ers working at their facilities have as much safety training as is feasible;and regulators cracking down on training requirements by issuing civilpenalties for the use of unqualified radiographic personnel. In the late1970s, the State of Louisiana assessed its first civil penalty in the amountof $5,000 to a company for using an unqualified radiographer. It was laterreduced to $2,500, but it did succeed in attracting the attention of theradiography community.

Another contributing factor may be that there has been a slump in oil andgas exploration in recent years, providing these firms an opportunity toretain only the better employees. Some think that the largest contributingfactor is that radiographers appear to be taking more responsibility for theirown actions. The impetus for this is being provided by movement towardcertification cards, diligent inspection efforts, stiffer enforcement byregulatory agencies, and an increasing potential for the employee to beindividually cited for violations and, perhaps, even fined.

There appears to be evidence, nationwide, that the number of excessiveexposures to operating personnel has, indeed, decreased over the past fewyears. It is probably impossible to identify a single reason for this trend,but most likely, it is due to a combination of all of the above efforts beingmade on the part of many individuals, firms, and agencies.

To a casual observer, it would appear that state efforts have largelyconcentrated on improvements in training radiography personnel, improvementsin regulations, more inspections, and proper use of survey meters, whereas theNRC efforts seem to be more concentrated on equipment design and performance,including fail-safe devices, alarming rate meters, improved connectors (basedon requirements developed by Texas in the mid 1980s), etc. The incorporationof an American National Standards Institute (ANSI) standard into the NRC's10 CFR 34 has resulted in the most significant change regarding equipmentdesign and performance. The cognizant ANSI committee consists mainly ofindustry representatives from Agreement States.

The above is not to say that either group has excluded other efforts,however. The result has been a noticeable improvement in the radiographyindustry over the years, although it is doubtful that such improvements willever completely preclude the type of excessive exposures that seem to plaguethe radiography industry, but this should not hinder further efforts forimprovement.

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C. Generally Licensed Devices

General licenses are those licenses issued to an identifiable group ofpersons for the use of radioactive material that does not require a specificlicense, yet the use is not exempt from regulatory control. Specifically, thedegree of regulatory control is between that required of a specific licenseand an exemption. Some general licensees are typically identified by thedevice manufacturer providing regulatory agencies with the names of persons towhom they have shipped the device. General licensees are not authorized tomanufacture, distribute or repair devices or products. The actual generallicense (GL) is incorporated into the regulations, and everyone in theidentified group has the "general license." The degree of regulatory controlvaries with each GL, and any restrictive conditions are contained in theregulation for that GL. It is important to note that a general licensee canbe inspected and, if in non-compliance, is subject to all of the enforcementactions applicable to a specific licensee. The following sections identifyeach GL currently in effect as a federal regulation and by Agreement Stateswith equivalent regulations.

1. 10 CFR 31.3. Certain Devices and Equipment

This general license authorizes the use of static elimination devices andion-generating tubes. The GL limits the use to those devices and tubes whichare specifically manufactured for this GL. The GL is extended to anyone whouses such devices. The general licensee may not transfer the radioactivematerial to persons exempt, must maintain labels, must confine use to themanufacturer's instructions, must file incident reports and transfers must beto a specific licensee or to a general licensee. Possession is limited to500 microcuries of polonium-210 per static eliminator device or ion-generatortube, and 50 millicuries of hydrogen-3 per ion-generator tube. North Carolinafeels there are some problems with this GL, since the identity of users is notknown automatically.

2. 10 CFR 31.5. Certain Measuring, Gauging or Controlling Devices

The original version of this GL was implemented by the AEC in the early1960s. This general license is currently the one most utilized. The devicesmay be used by commercial and industrial firms, research, educational andmedical institutions, individuals in the conduct of their business andagencies at all levels of government. The GL does not limit the amount ofradioactive material that may be in a device. The quantity and isotope ofradioactive material is limited by the specific manufacturing license. Devices have been licensed for up to four curies of cesium-137 and 20 curiesof tritium. The GL requires the user to follow the labeled instructions andthe manufacturer's instructions. Leak tests are required for non-gas sourcesas well as off-on tests, if such is a part of the device. Transfer may beonly to a specific licensee, or if in a fixed facility, to a successorfacility owner. Disposal is through a specific licensee unless sufficientdecay has occurred. The manufacturer/distributor is required to report thetransfer of all devices quarterly to all regulators. Some Agreement Statesalso require the general licensee to report the receipt of such devices within10 to 30 days of receipt. Records of receipt, transfer, area surveys andincidents are required. All labels must be maintained in legible condition.

14 The word ‘radioactive’ is included here since Agreement States applythis GL to all radioactive material.

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The state of North Carolina always has had an active program for 31.5 typedevices. If the devices are authorized to be possessed under the states'equivalent general license, the licensee may choose to possess them under anexisting specific license, but all the conditions of that specific licenseapply to the GL devices. If this option is chosen, the licensee is inspectedat the same frequency as the rest of the license requires. Licensees possess-ing devices under the GL are inspected at four-year intervals unless they havea large number of devices (about 25), when they are inspected at three-yearintervals. The North Carolina system involves billing the general licenseefor a fee on an annual basis, thereby aiding in the accountability of thedevices. Many other Agreement States also charge fees.

3. 10 CFR 31.6. General License to Install Devices Generally Licensed in § 31.5

As an administrative convenience, this GL allows one regulatory jurisdic-tion to recognize a licensing document of another like jurisdiction forspecific uses. The recognized uses are to install devices authorized by§ 31.5.

4. 10 CFR 31.7. Luminous Safety Devices for Use in Aircraft

Aircraft pass through many regulatory jurisdictions, and as an adminis-trative convenience as well as for safety considerations, a GL is the effec-tive way to control the use of these devices. This GL authorizes the posses-sion and use of luminous "EXIT" signs on aircraft. As with all other GLs, thedevices must be manufactured pursuant to a specific license. The maximumauthorization limits under this GL are 10 curies of hydrogen-3 and 300 milli-curies of promethium-147 per device. The general licensee is to reportincidents and maintain the records specified for the GL in § 31.4.

5. 10 CFR 31.8. Americium 241 in the Form of Calibration Reference Sources

Anyone who has a specific license is expected to perform calibration ofradiation detectors or to standardize other sources. This GL automaticallyprovides for such sources without an additional application. This GL isavailable only to specific license holders. The GL is limited to five micro-curies of americium-241. The states have added radium-226 to this GL.

6. 10 CFR 31.9. General License to Own Byproduct (Radioactive)14 Material

This GL allows anyone to own byproduct (radioactive) material. It doesnot authorize manufacture, receipt, transfer, production, possession, use,import or export of radioactive material.

7. 10 CFR 31.10. General License for Strontium-90 in Ice Detection Devices

This GL is for anyone to possess, use, receive or transfer ice detectorscontaining strontium 90. The maximum amount of radioactive material allowedis 50 microcuries per device. Retention of labels and reporting of incidentsare the requirements for this GL.

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8. 10 CFR 31.11. General License for Use of Byproduct (Radioactive) Material for Certain In-Vitro Clinical or Laboratory Testing

Any physician, veterinarian, hospital or clinical laboratory may useiodine-131, iodine-125, carbon-14, hydrogen-3, iron-59, selenium-75, and mockiodine-125 for clinical testing. The GL requires registration with theregulatory agency and limits the total possession to 200 microcuries. Further, pursuant to the GL, the material must be stored in the originalshipping packages or their equivalent, and all transfers must be in unopenedcontainers to a specific licensee or someone authorized to utilize this GL.

9. NOTE: 10 CFR 40.13. is an exemption even though it has regulatory requirements. The requirements generally relate to concentrations of source material in various products or the type of product in which it is contained.

10. 10 CFR 40.21. General License to Receive Title to Source or Byproduct Material

See 10 CFR 31.9 above.

11. 10 CFR 40.22. Small Quantities of Source Material

This general license is issued to the same persons as listed in10 CFR 31.5. above. It authorizes 15 pounds of source material to be trans-ferred at a time to the general licensee with not more than 150 pounds to betransferred in a year. The GL does not permit the use of the source materialon or in humans. There are no reporting requirements for this GL.

12. 10 CFR 40.23. General License for Carriers of Transient Shipments of Natural Uranium Other Than in the Form of Ore or Ore Residue

This GL implements the federal control of imports and exports; therefore,it does not appear in the Agreement States regulations. The GL is set toassure the physical safeguarding of large shipments of natural uranium.

13. 10 CFR 40.25. General License for Use of Certain Industrial Products or Devices

This GL is for source material for shielding or weights and is issued toanyone. The GL is required to register with the regulatory agency. Nochanges to the source material may be made by the GL. Transfers may be madeto either general or specific licensees if a copy of the GL and registrationform also are provided.

14. 10 CFR 40.26. General License for Possession and Storage of Byproduct Material as Defined in Part 40

This GL allows the mill tailings and solution wastes to be stored withoutamending a specific license. There is no quantity limit other than thespecific license limit. The GL allows storage and necessary transport inauthorized containment areas. The GL terminates with the expiration ortermination of the specific license or when the specific license is renewedwith financial assurances.

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15. 10 CFR 40.27. General License for Custody and Long-Term Care of Residual Radioactive Material Disposal Sites

This GL is for any site for which the NRC has accepted a long termsurveillance plan for a disposal site under Title I of UMTRCA. This is toallow for the orderly transfer from a Title I site to a long-term careprovider (DOE).

16. 10 CFR 40.28. General License for Custody and Long-Term Care of Uranium or Thorium Byproduct Materials Disposal Sites

Similar to 10 CFR 40.27 for Title II UMTRCA sites, although a state may bethe provider of long-term care.

17. 10 CFR 150.20. Recognition of Agreement State Licenses

This general license is supportive of interstate commerce and adminis-tratively allows the recognition of another agency's license. The GL requiresprior notice to the jurisdiction receiving the material and the possession bythe GL of a specific license that does not limit the location of use ofradioactive material. The licensee must also maintain radiation-relatedrecords in the jurisdiction that issued the specific license being recognized.

18. Problems Associated with General Licenses

A number of concerns have been raised by the Agreement States and othersover the years, particularly as related to the 31.5 GL. Most problemsassociated with radioactive materials possessed and used under a generallicense have been identified with this particular GL.

Some of the problems identified were:

a. Improper transfers from one general licensee to another generallicensee.

b. Failure of the manufacturer/distributor to provide a contact name forthe general licensee.

c. Some concern that all transfers were not being reported.

d. The sale of a facility to another company with no accountability forthe devices.

e. Failure to maintain labels and perform function and leak tests. This is particularly a problem in industries in which corrosive atmospheres are present.

f. Concern over generally licensed devices (sources) appearing in scrapmetal.

As a result of these identified problems, some changes were made in 1984 tothe general license. These were:

a. Authorization for general licensee to general licensee transfers forsome devices.

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b. Requirement that the name of a contact be included in the reportsprovided to the regulatory agencies, and the requirement for anegative report when no devices were transferred.

c. Specific authorization for the transfer to the new owners of amanufacturing plant of any fixed devices.

At approximately the same time, several states (Texas, South Carolina,North Carolina, Florida) began to identify other possible problems. Thesewere:

a. Inadequate awareness of general licensees that they possessed radio-active material.

b. The use of large (>500 millicuries) gamma sources such as cesium-137in GL devices.

c. The installation of alpha-emitting devices in severe environments.

d. The failure to provide copies of the GL to the recipients.

e. The failure of the manufacturer to notify the regulatory agencies ofdesign changes.

The NRC also identified the severe environment problem when several 3MCompany devices were found to be leaking. The manufacturer had modified thesources without the approval of the NRC.

South Carolina and Florida had reported questions regarding the use ofstatic eliminators on food production lines, and Florida raised questionsregarding their use in the phosphate industry. Texas and Florida raisedquestions regarding the use of large gamma sources. These sources were beingused on large vessels where maintenance personnel were working. Concern wasexpressed about the adequacy of the safety programs at facilities that mightnever have been inspected. During the late 1980s, the NRC attempted tocontact a group of GLs. A significant number could not be located or indicat-ed that they were unaware they possessed a radioactive source. Severalstates, including Alabama and Florida, also inspected their GLs. The resultsvaried with the degree of regulatory involvement. Awareness by the GL washigher in a state that required the reporting by the GL within 10 days ofreceiving the radioactive material. The longer a source was possessed by aGL, the less likely that management was aware they possessed the radioactivematerial.

A recent problem identified by Tennessee was the mounting of a GL deviceon a barge. The barge worked in several states, then was scrapped; the scrapended up in Tennessee. Louisiana and Alabama also were involved. Alabamaalso has identified at least one truck-mounted GL device that has worked inseveral jurisdictions. The mobile use of this GL has raised many questions ofthe legitimacy of the practice. After Illinois became an agreement state, itdiscovered that the NRC database of GL's was not current. A series of mail-out survey questionnaires resulted in elimination of more than two-thirds ofthe GLs. There is no reasonable way of determining what happened to theradioactive material formerly possessed by these GLs.

15 By letter dated July 27, 1970 from the U.S. Surgeon General toDr. R. L. Cleere, Colorado Department of Health, exposure guidelines applica-ble to cleanup of homes constructed with or on uranium mill tailings were provided to the state.

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Suggestions to improve this GL include:

a. Telephone or mail contact with the GL at least once every five years.

b. Inspecting at least ten percent of the GLs that do not also have aspecific license.

c. Placing more responsibility on the manufacturer for accountability ofdevices.

There has been some discussion within the NRC that the exemptions and GLsin 10 CFR 40 (source material) need a comprehensive revision and possiblemodifications. In October 1992, the NRC published NUREG/CR-5881 titled, "AnExamination of Source Material Requirements Contained in 10 CFR Part 40." That document presents some of the major issues to be considered in any suchrevision. On Oct. 28, 1992, the NRC published an Advance Notice of ProposedRulemaking on this subject.

D. Uranium/Thorium Mill Regulation

The regulation of uranium and thorium mills originally came under theumbrella of source material licenses. Thus, when any state entered into asection 274 agreement with the AEC, the state assumed authority over thesefacilities along with other source material licenses of more limited scope. No specific regulations addressed mills as a class, although the AEC had a fewmodest guides and had one engineer on staff who evaluated the structuralaspects of tailings impoundments.

Even though some states, notably Colorado, had raised concerns aboutpotential hazards from mill tailings and, indeed, Congressional hearings hadbeen held on the subject, the issue did not receive high priority at thefederal level until the late 1970s.15 The AEC position was that, although theAEC could exert control over all aspects of the mill during operations, noregulatory control could be exerted over tailings after termination of alicense. This was because the principal hazard came from radium, which was anaturally occurring radioactive material and not subject to the Atomic EnergyAct, and the concentration of source material (uranium) in the tailings wasless than 0.05 percent by weight, which was the cutoff for licensing.

Due to increasing concern about the environmental impacts and pressurefrom environmental groups (particularly the Natural Resources Defense Coun-cil), Congress enacted the Uranium Mill Tailings Radiation Control Act of 1978(UMTRCA, P.L. 95-604) that established a number of new requirements for thesefacilities. The U.S. Department of Energy (DOE) had submitted the proposedlegislation in April 1978. Title I of UMTRCA included provisions for reclama-tion of non-commercial facilities that were to be carried out by the DOE.Title II of the Act gave the NRC regulatory authority over mill tailings inthe commercial sector. The NRC interpreted UMTRCA's definition of byproductmaterial to include above-ground wastes from in-situ extraction operations and

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uranium and thorium tailings. The new requirements of UMTRCA would not takeeffect in Agreement States until 1981. In the interim, the NRC issued generallicenses in these states to licensees that were involved in activities thatgenerated byproduct material. These licenses were valid until Nov. 8, 1981,three years after the effective date of UMTRCA. The National EnvironmentalPolicy Act of 1969 (NEPA) was the standard the NRC used when reviewing millinglicenses. This required federal agencies to prepare an environmental impactstatement (EIS) considering environmental consequences of any major actionthat could have a significant effect on the environment.

The NRC prepared a Generic Environmental Impact Statement (GEIS) address-ing the issue. The purpose of the GEIS was to assess the nature and extent ofthe environmental impacts of conventional uranium milling in the UnitedStates, provide information that would support new regulatory requirements forthis industry and support any rule change that might be deemed necessary. TheAgreement States with mills could continue regulating them until Nov. 8, 1981(a date which was later extended), but had to adopt the new regulatoryrequirements and generally upgrade their programs by adding more staff,obtaining new equipment and adopting new procedures. The NRC published newcriteria for those states desiring to enter into amended agreements for milland tailings regulation on Jan. 23, 1981. The NRC provided assistance toAgreement States in performing environmental reviews for proposed mill licen-sing actions until 1981. UMTRCA required that after 1981 the Agreement Statemust perform environmental impact analyses that must include impacts to publichealth and safety, impacts to waterways and ground water and consider anylong-term impacts such as decommissioning, decontamination and reclamation.

Prior to UMTRCA, there were no requirements pertaining to site ownership. UMTRCA states that before terminating any license, title to the land used forthe disposal of tailings shall be transferred to the United States or to thestate in which the land is located. This requirement could be waived if theNRC determines, prior to license termination, that the transfer is notnecessary to protect public health and safety. The ultimate custodian of theproperty shall maintain the land in such a manner as to protect public healthand safety as well as the environment.

UMTRCA also added section 275 to the Atomic Energy Act. This sectiongranted authority to the Environmental Protection Agency (EPA) to establishstandards (40 CFR 190 and 192) of "general application," covering both radio-logical and other hazards from mill tailings located at active mill sites. The NRC or Agreement State was responsible for enforcing these standards.

In Part 190, promulgated in January 1977, the EPA established a dose limitof 25 millirem per year to the general public from active uranium fuel- cycleoperations. Part 192, adopted in October 1983, required stabilization oftailings so that associated health hazards could be controlled, preferably for1,000 years and, in any case, for 200 years. It required that disposal pilesbe designed to limit radon releases to 20 picocuries per square meter persecond, averaged over the surface of the disposed tailings. Part 192 requiredthat measures be taken to limit the release of hazardous material, includingradioactive material, from tailings into ground and surface water. Thesemeasures included liner installation in new impoundments and correctiveactions to restore contaminated ground water.

16 On Nov. 19, 1993, the NRC issued a license to Envirocare of Utah, Inc.,authorizing the receipt, storage, and disposal of section 11e.(2) byproductmaterial at a site near Clive, Utah. This is the first and only licenseissued to date that authorizes such activities on a commercial basis.

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In response to the Clean Air Act, the EPA promulgated additional standardsin 40 CFR 61 to ensure that tailings piles would be closed in a timely manner. It requires that once a tailings pile or impoundment ceases to be operational,it must be closed and brought into compliance with the standard within twoyears of the effective date of the standard (by Dec. 15, 1991) or within twoyears after it ceases to be operational, whichever is later. It also requiressubmission of a tailings closure plan and a final test of the barrier at afacility to determine compliance with radon flux emission limits. This rulebecame effective Jan. 14, 1994.

When UMTRCA was passed in 1978, there were four Agreement States regulat-ing mills - Colorado, New Mexico, Texas and Washington. However, there wasthe potential for milling activities in other Agreement States such asArizona, California and Oregon. Section 207 of UMTRCA provided $500,000 ingrant money to assist the Agreement States in upgrading their regulatoryprograms. The larger grants were given to Colorado, New Mexico, Texas andWashington, but modest grants were provided to several other Agreement States. Eventually Washington, Texas and Colorado entered into amended agreements withthe NRC on Feb. 19, 1982, March 24, 1982 and April 20, 1982 respectively. Asnoted earlier in this report, New Mexico relinquished this authority back tothe NRC on June 1, 1986.

No other Agreement State pursued an amended agreement to a final stageexcept Illinois. The only commercial thorium facility in the United Stateswas located in West Chicago, Illinois. Although the facility ceased opera-tions in 1973, it has not yet been closed out. Even though the NRC recognizedthat the on-site material was section 11.e(2) byproduct material (tailings),it never regulated this material in the same manner as similar facilities inthe western United States. Illinois obtained an amended agreement on Nov. 1,1990 to regulate mill tailings facilities. As this report is being written,the facility currently has a pending application with Illinois to decommissionand close out the facility. Initial shipments of material to Envirocare beganon Sept. 9, 1994.16

The remainder of the discussion in this section is primarily a descriptionof the Texas program for regulation of milling activities. Texas had a largenumber of underground solution mining operations in addition to a few conven-tional mills. The solution mining operations do not generate large quantitiesof tailings (wastes) above ground, so some aspects of the Texas program areunique to that type of operation. Nevertheless, this discussion should behelpful in understanding the regulatory aspects of this industry. Table 2 maybe of particular interest since it lists some unique features of pre-UMTRCAand post-UMTRCA regulatory programs.

1. Uranium Mining and Milling in Texas

Uranium was first mined in Texas in 1959. In 1961, Susquehanna Western,Inc. built a mill near Deweesville, Texas and began processing ore that hadalready been mined. In 1968, a second mining area was started by Susquehanna

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Western near Three Rivers, Texas. A number of other operations were developedfrom 1968 - 1981.

Table 2. Uranium Facility Regulation and UMTRCA

Pre-UMTRCA

1. Specific rules pertaining to licensing and operation of uranium recoveryoperations did not exist.

2. Financial surety was not required.

3. Pre-licensing environmental assessments were not required.

4. Specific impoundment design requirements did not exist.

5. Long-term care and ultimate land disposition was unclear.

6. Radon emanation from tailings was not addressed.

7. Specific inspection criteria and interval not established.

Post-UMTRCA

1. Specific rules regarding licensing and operation of uranium recoveryfacilities were adopted.

2. Title transfer of tailings impoundment property was established.

3. Pre-licensing environmental assessment became mandatory.

4. Financial surety was required to ensure proper decontamination andreclamation of uranium recovery facilities, and for long-term surveil-lance.

5. Mandatory submission of closure plan and estimated timetable for reclama-tion were required.

6. Environmental monitoring of air emissions (including radon) and ground-water was required.

7. Specific impoundment construction criteria were established that requiredliner placement and limited erosion.

8. Worker bioassays were required and limits established.

9. Six-month inspection interval established. Responsibility of inspectiontransferred to the state.

10. State environmental monitoring programs around impoundment facilities wereestablished.

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Solution (in-situ) mining was begun in Duval and Live Oak counties about1968. This employed a new technology that was less environmentally damagingand lowered doses to both workers and the general public.

As of Oct. 1, 1981, the Bureau of Radiation Control had 19 active licensesfor uranium recovery operations and four new applications under review. TheSusquehanna Western site near Deweesville was named as one of the processingsites in Title I, section 102 of UMTRCA. In 1992, the Bureau of RadiationControl had eight in-situ facility licenses for 16 sites and three licensesfor conventionally mined ore processing and tailings impoundments.

2. Environmental Surveillance at Texas Uranium Facilities

In 1981 the Bureau of Radiation Control established formal environmentalsurveillance programs at 18 facilities. One full-time employee performedsurveillance activities. Prior to that date, inspectors did limited samplingat these sites as part of their inspection procedure. The original surveil-lance activities around the conventional uranium facilities were quite modest.

During 1987 and 1988, programs were established that greatly expanded themonitoring programs, increasing monitoring frequency and including media suchas soil, vegetation, groundwater and use of TLD monitors.

In 1987, the bureau performed surveillance activities at 28 sites. Thislist included the three original conventional mill facilities as well as theExxon-Ray Point impoundment and three in-situ facilities.

3. Texas Regulations for the Control of Radiation

The Texas Regulations for Control of Radiation (TRCR) were adopted by theState Board of Health in accordance with the Texas Radiation Control Act. They became effective on March 1, 1963 and have been amended several times tobe kept compatible with NRC regulations. These regulations, as well asindividual license conditions, are the basis for any facility inspection.

Part 43 of the TRCR, "Licensing of Uranium Recovery Facilities" was adopted in October 1981. This part addresses license application, generalrequirements for license issuance, financial security requirements, long-termcare/maintenance requirements, license renewal, technical requirements forimpoundments, transfer of material and land ownership. Among other things,these rules were necessary to include in the state's request for an amendedagreement with the NRC.

There have been a number of other changes to the Texas regulationscovering such items as fees, notification of bankruptcy, submission of closureplans, environmental monitoring requirements and the role of the TexasDepartment of Water Resources. Table 3 is a chronology of significant eventsin the development of the Texas program.

4. Inspection of Texas Uranium Facilities

In 1961, the state of Texas enacted the Radiation Control Act. This lawestablished the state's authority to license and regulate the possession anduse of radioactive material. Texas became the fifth Agreement State onMarch 1, 1963. It assumed regulatory authority over approximately 500licenses issued by the AEC, which included one uranium facility. The law

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Table 3. Significant Events in Uranium Regulation in Texas

Date Event

April 17, 1961 Texas Radiation Control Act

January 10, 1963 Texas/USAEC Agreement signed

March 1, 1963 Agreement became effective

June 6, 1963 First uranium mill licensed

1963 Tailings disposal areas required to be lined

1963 Use of tailings in construction of tailings dams prohibited

August 15, 1968 First in-situ solution mining pilot project licensed

March 11, 1970 First Texas conventional uranium mill licensed

September 1972 Uranium mining was made a generally licensed activity

February 1973 First tailings pond restoration standards issued

May 7, 1973 First standards for the abandonment of uranium mines established

December 17, 1975 First in-situ mining project licensed

February 1976 First soil contamination guidelines established

August 1978 Amendment to all uranium licenses with dryers requiring bioassay

May 21, 1979 First environmental assessment issued

April 1980 Letter issued outlining UMTRCA requirements

April 1 & May 22, 1981 Texas Radiation Control Act amended to include UMTRCA provisions

October 1981 Part 43 "Licensing of Uranium Recovery Facilities" adopted

March 24, 1982 Amended agreement with NRC regarding mills

1982 Financial security requirements set

1982 Reclamation cost estimates set by TDH

September 1993 Authority to regulate uranium recovery operations transferred toTexas Natural Resource Conservation Commission

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designated the Texas State Department of Health (TDH), now known as the TexasDepartment of Health, as the Texas radiation control agency. At the time, theRadiation Control Branch was within the department's Division of OccupationalHealth and Radiation Control. This branch was responsible for developing andimplementing a program for licensing and regulating radioactive materials.

In 1981, the Texas Radiation Control Act was amended to include all theprovisions of law required by UMTRCA. The Radiation Control Branch became theBureau of Radiation Control. This bureau consisted of three divisions and anadministrative support office. In addition, three attorneys from the TDH'sLegal Division and five chemists from TDH's Bureau of Laboratories assistedwith uranium facility regulation efforts.

The Division of Compliance and Inspection, part of the Bureau of RadiationControl, had the responsibility for inspecting uranium recovery operations. Within this division is the incident investigation program. This programinvestigated any reports of employee overexposure. Bioassay results ofgreater than 30 micrograms per liter of uranium required immediate bureaunotification. This action level, suggested by the NRC, was based on uraniumtoxicity, not radiological hazard. This bioassay requirement was incorporatedinto all uranium facility licenses that had a dryer. The incident investiga-tion program also would examine any reports of significant fluid release fromany of the uranium recovery facilities.

Inspections of uranium facilities prior to 1979 were performed using ageneral inspection guide developed by the Bureau of Radiation Control. Thisform used a "check box" format and allowed little room for additional inspec-tor comments or observations. Inspections were done on an annual interval. In 1981 the inspection interval was changed to every six months. A narrativeformat for the inspection report was utilized. The inspection guide becamemore specific for uranium facilities and in 1990 guides were developed foreach specific license. These guides included specific requirements documentedin the license, application and TRCR and allowed for a "tailor-made" inspec-tion of a facility and a specific narrative report of the inspection.

Three other state agencies are involved in regulating the uranium industryin Texas. The Texas Railroad Commission regulates surface mining. The TexasAir Control Board regulates air emissions, excluding radionuclides, from thesefacilities. The Texas Department of Water Resources regulates the release ofpollutants into groundwater and permits injection and disposal wells.

In September 1993, Senate Bill 1043 transferred regulatory jurisdictionfor all uranium recovery facilities to the Texas Water Commission, formerlythe Texas Department of Water Resources, now called the Texas Natural ResourceConservation Commission. The Texas Air Control Board is also part of thisorganization.

E. Regulation of Low-Level Waste Disposal

In 1960 the AEC announced that it would support the development of low-level radioactive waste disposal sites throughout the country to be operatedby the commercial sector for the fast-developing nuclear industry and nuclearpower plants. This was a new concept since most disposals were allowed onlyat federal facilities. It was prompted in part by the AEC's moratorium placed

17 Same company and location as noted in footnote 16.

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on sea disposal of wastes and its plans to close burial grounds at Oak Ridge,Tennessee and the National Reactor Test Site in Idaho to commercial waste,once adequate capacity was established at new sites in the private sector.

The Agreement States played a major role in the development of regulatorylicensing and oversight of these commercial facilities, since five of themwere located in Agreement States. One was located in Illinois, which at thattime was not an Agreement State. The states have the authority to license andregulate byproduct, source material and limited quantities of special nuclearmaterials (SNM). The NRC also is involved to a lesser degree in regulatingthese sites for large quantities of SNM. At the time of this writing, onlyone of the original sites is open to waste from throughout the country fromqualifying states and compacts, and one to waste from only its compact andanother compact with which it has a contract. A seventh site has been openedin Utah17, but it has not been subjected to the same regulatory requirementsas the others, because it is only allowed to accept small concentrations ofby-product material and small concentrations of naturally occurring radioac-tive materials (NORM).

Since the opening of commercial disposal sites there have been manydramatic changes in regulations, disposal technologies, waste forms andpolitical forces. Much of this was brought about by problems experienced atthe burial sites in the late 1970s, the increased concentrations of radio-nuclides in the waste forms, problems with waste packaging in transportationand at the burial sites, and the public perception of waste disposal. Some ofthese changes had a sound health and safety basis, whereas others werepolitically motivated. The Low Level Radioactive Waste Policy Amendments Actof 1985 (LLRWPAA) has had the most profound effect. It provided a series ofmilestones and penalties for the states and compacts to meet.

The low-level waste regulatory program directly affected the six stateswhere original sites were located and later those that were developing sitesunder the compact system. However, the indirect effect was on thousands ofgenerators located in all 50 states plus citizens of all states which could beaffected by the transportation of these wastes.

It should be noted that, of the initial six sites, all but the Hanfordsite were located on state-owned land (Hanford was on federal land leased tothe state). Thus, these five host states could exert ownership leverage onthe operators of these sites. In addition, the six original sites weredeveloped as a private- sector oriented market venture compared to the quasi-governmental venture resulting from the LLRWPAA. The original system wasrather successful from a distributional aspect, but less than successful froma technical and management perspective.

1. Sequence of Facility Openings, Problems and Closingsa. he Beatty, Nevada site was the first commercial site to open in 1962.

The site is located on an 80-acre tract of arid Amargosa Desert landapproximately ten miles from the small town of Beatty and 100 milesnorthwest of Las Vegas. The site is approximately 2800 feet above sealevel with a groundwater table depth of 300 feet. There is no appre-

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ciable surface water for 10 miles. Rainfall averages two to fiveinches per year with a much higher evaporation rate. Technically,these conditions are excellent for shallow land disposal. There isalso a hazardous waste disposal site adjacent to the Beatty facility.

The site was originally operated by Nuclear Engineering Company(NECO), which later changed its name to US Ecology. It incorporatedthe shallow land disposal technology with a final trench cover of10 feet. Technically the site has had no problems, but has been some-what mismanaged. Employees were allowed to remove certain tools andbuilding materials that may or may not have been contaminated, andwaste was found disposed outside of the fenced area. In the late1970s, some of the shipments arriving at the facility were found tohave significant violations of transportation regulations. After oneevent when a truck caught fire due to improper packaging of waste, thesite was closed by the Nevada regulatory officials until assuranceswere made by each state, generator and the federal government that allhealth and safety and transportation regulations would be adhered toand enforced.

Following passage of the LLRWPAA, the Beatty site was chosen as theregional facility for the Rocky Mountain Waste Compact, and as such,the site was subsequently closed in December 1992 as authorized by theact. The state of Colorado was selected as the next host state, butsince then the Rocky Mountain Compact has contracted with the North-west Compact to accept its waste at the Richland (Hanford), Washingtonsite.

b. NECO, now US Ecology, also operated the Maxey Flats, Kentucky site. The site opened in January 1963 and was to provide disposal service tothe fast-growing nuclear industry in the middle Atlantic states,Southeast and some of the Northeast. This site is located nearMorehead, Kentucky, approximately 65 miles northeast of Lexington,Kentucky. In December 1977 the site was closed after it was deter-mined that radionuclides from one trench were seeping into an adjacenttrench.

The main problems encountered at the Maxey Flats site are attrib-utable to the shale and sandstone bed that was approximately 25 feetbelow the disposal trenches. Significant amounts of water wouldaccumulate in the trenches since the infiltration rate into thetrenches was much greater than the out-flow through the soil. This iscommonly called the "bathtub effect." This led to considerablemigration of radionuclides, especially tritium.

The state of Kentucky decided to take control of the site and initiateremedial action. The program first involved pumping contaminatedwater and treating by various methods to remove radioactivity. Inaddition, a synthetic membrane was installed over the trenches toreduce the amount of water percolating into the trenches. This provedvery beneficial. The site was closed on Dec. 27, 1977. Followingnegotiations with the site operator, Kentucky signed an agreement withNECO in May 1978 whereby the lease rights to the site were bought backby the State.

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By the mid-1980s the environmental sampling at the site indicated thatradionuclides could potentially migrate from the site, and this causedconcern from a health and safety standpoint. Therefore, the common-wealth of Kentucky requested that the EPA place the site on theSuperfund list in order to receive funds for remediation and designateentities that had disposed of waste there as potentially responsibleparties. They would be responsible for reimbursement to the Super-fund. More than 800 parties were named by the EPA. Immediatelythereafter, the EPA began a process to have all the contaminatedliquids that were being stored in tanks solidified into concreteblocks and placed in a new trench specially constructed for thatpurpose. Remediation continues at this site to date.

c. In 1963 Nuclear Fuel Services opened the West Valley, New York commer-cial low-level waste site at its Nuclear Service Center approximately30 miles southeast of Buffalo, New York. The 22-acre site operatedunder a lease agreement with the state of New York until March 1975. At that time the site was closed from further disposal operations whenwater overflowed or seeped upward through the covers of several of thedisposal trenches. Percolation of above-normal rainfall over a periodof time through the trench covers contributed significantly to theaccumulation of water in the trenches. It also was discovered that asubsurface sand and gravel area near the disposal trenches may haveacted as a conduit and directed large quantities of groundwater intothe trenches.

A trench cap rehabilitation program was undertaken by the New YorkEnergy Authority, but water continued to infiltrate the disposaltrenches. Recent indications, however, show that water continues toinfiltrate some of the trenches despite pumping efforts previouslycarried out and cap remedial action. Plans presently call for theremoval and treatment of water in one of the trenches with the mostsignificant accumulation.

The West Valley site continues to be shut down from all disposaloperations and there are no plans to reopen it. However, there havebeen discussions to locate another disposal facility for only New YorkState generated waste at the West Valley location.

d. The Richland, Washington commercial low-level waste disposal site waslicensed in 1965 and was operated by California Nuclear, Inc., but waslater transferred to Nuclear Engineering Company (NECO), subsequentlyrenamed US Ecology, Inc. The site is located on the DOE HanfordReservation about 25 miles northwest of Richland, Washington in thesoutheastern part of the state. The site is approximately 100 acresand is leased from DOE by the state of Washington.

The Richland site is unique in that it is situated on sediments thatwere fed by glaciers in a semiarid area about 200 feet deep. Belowthis is another 1,200 feet of sedimentary material above a bedrock ofbasalt. Surficial silt and sand cover the site and are susceptible tomovement by wind. The depth to the water table is approximately 350feet. The closest surface water is the Columbia River, which flowsabout six miles from the site. There is an annual precipitation ofabout six inches per year with a 55-inch-per-year evaporation rate.

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This site is ideal for low-level waste disposal due to the aridconditions. Problems associated with silt-sand cover can be rectifiedwith a proper cap. Despite this, however, the site was closed to out-of-region waste in 1992, but continues to accept NORM nationally on alimited basis.

With the exception of some soil contamination problems associated withunderground tanks used to hold liquids and resins in earlier years ofoperation, the site has had very few problems from an operational andenvironmental standpoint. However, the site was closed in 1979 fortwo months, as was the Beatty site, when transportation and packagingviolations were found. It was reopened once the state of Washingtonwas assured that the federal government (NRC) would take adequateenforcement action against its licensees. Like Nevada and SouthCarolina, Washington established a formal transportation inspectionand enforcement program that contributed substantially to compliancewith applicable federal and state shipping regulations. These en-hanced requirements came about in part as a result of visits to theNRC Chairman and other federal officials and members of Congress byGovernors Riley, Ray, and List (see Section VIII.E.4. below). Thethree Governors expressed the need for new inspection and enforcementpractices for waste generators in a joint letter to NRC ChairmanHendrie dated July 10, 1979. Chairman Hendrie replied positively tothe Governors' proposals by letter dated July 18, 1979.

e. The Sheffield, Illinois site is located in Bureau County, approxi-mately 120 miles west of Chicago, and was opened in 1966 by CaliforniaNuclear, Inc. The license was later transferred to NECO, now U.S.Ecology, Inc. The site was closed in April 1976 when it reached itsplanned capacity. The site was licensed by the NRC until June 1987when the State of Illinois became an Agreement State, and it assumedresponsibility.

There are also two hazardous chemical waste disposal areas locatedapproximately 150 feet from the low-level radioactive waste site. These have since been closed as well. The site is approximately 20acres and is situated on a glaciated terrain, which consists of lakedeposits of silt and clay, and a sandy soil cover. The site isunderlain by both shallow and deep aquifers. A 450-foot bedrock areaseparates the two groundwater units. A small lake (Trout Lake) alsois located near the disposal site. The climate is relatively humidand the site receives approximately 35 inches of rain annually. Wastewas buried in 21 trenches typically 500 feet long, 60 feet wide and 25feet deep. During its operations, it received approximately 3 millioncubic feet of waste.

In 1976, tritium was detected migrating toward Trout Lake northeast ofthe site. Other samples taken indicated tritium was migrating fromTrench 11, and that groundwater movement exceeded initial estimates. The U.S. Geological Survey (USGS) conducted extensive studies at thesite and determined greater groundwater movement than expected of 10to 20 feet per year, due to subsurface sand and coarse materials. Anew water management program was initiated at the site to directprecipitation runoff away from trenches and minimize infiltration.

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In order to extend the capacity of the site in 1975, NECO requestedthe NRC to approve new compact-filled trenches. Although the NRCapproved construction of the trenches, it never authorized disposal ofwaste in them. This caused the demise of any further site operations. In 1978, the site operator attempted to absolve itself of any furtherresponsibility for the site and to have its license terminated. Thestate of Illinois sued the company since there was a contractualagreement with the state. A settlement was negotiated, and US Ecologywas required to establish a long-term maintenance fund, complete allsite improvements, conduct an environmental surveillance program andmaintain the site for 10 years. In 1989, a new clay cap constructedover the entire site was completed to help prevent infiltration ofrain water, thus minimizing further migration of radionuclides.

f. In August 1969, Chem-Nuclear Systems, Inc.,(CNSI), submitted a licenseapplication to the South Carolina Board of Health for the disposal ofcommercial low-level radioactive waste on property they had acquirednear Barnwell, South Carolina. This property is adjacent to theSavannah River site and the Allied General Nuclear Fuel Services(AGNS) processing facility that was under construction at that time. AGNS was decommissioned before it began operations. The site isapproximately 70 miles southwest of Columbia, South Carolina.

Although there were other commercial sites operating throughout thecountry, South Carolina initially supported a commercial facility inthe state, since it was becoming heavily involved in the commercialnuclear industry. It was perceived from an economic standpoint thatthis site would serve the state and surrounding states in the South-east that were also developing commercial nuclear power. Little didthe state know at that time that Barnwell would become the nation'slargest commercial disposal facility due to the closure of othersites. This prompted numerous political actions such as the LLWPA of1980 and the LLWPAA of 1985 requiring all states to assume the respon-sibility for low-level waste management and disposal.

An initial license was issued to CNSI on Nov. 6, 1969. However, thislicense restricted CNSI to receipt and possession of prepackaged wastefor transfer to other authorized disposal facilities throughout thecountry. Twenty months later, following a lengthy review process bymany state agencies and commissions, the AEC and the U.S. GeologicalSurvey, exchange of numerous documents and information in support ofland disposal, and one public hearing held March 4, 1971, an amendedlicense was issued to CNSI on April 13, 1971, authorizing disposal ofwaste at the Barnwell site. Also in April of that year, the landacquired by CNSI was deeded to the state and subsequently leased backto CNSI. The original perpetual maintenance fee was eight cents percubic foot, later raised to 16 cents, and is currently $2.80 per cubicfoot. There is more than $60 million in this interest bearing accountto provide long-term care and maintenance for the site. In addition,a decommissioning trust fund has been established with an $8 millionrequirement for funding. This will be used to decommission the siteand install a final enhanced cap.

Since operations began, the Barnwell site has received approximately34 million cubic feet of low-level waste. This contained more than

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300 million curies of radionuclides, which, when decayed to dateyields an inventory of 2.1 million curies, 3000 kilograms of specialnuclear material and 2.9 million pounds of source material.

The site encompasses more than 300 acres. Of that, 107 acres weredesigned for disposal of which 76 acres have been used with 31 acresremaining. This equates to approximately 10 more years of operationat a rate of 800,000 cubic feet per year, although 1.2 million cubicfeet is authorized annually.

The site was scheduled to close Dec. 31, 1992, but was granted anextension until Jan. 1, 1996. However, since July 1994 it is allowedto receive waste only from Southeast Compact States. The extensionwas to give the state of North Carolina additional time to develop thenext site as the new host state for the Southeast Compact.

This extension also prompted the state regulatory agency to requireimprovements in the site operations that will enhance performance andlong-term stability. Therefore, all Class B and C waste must bedisposed of in concrete overpacks, which are equivalent to below-gradevaults. All irradiated reactor core components must also be disposedin reinforced concrete-lined slit trenches with fitted concretecovers. Other improvements in waste forms and administrative proce-dures were also required.

Like the Beatty, Nevada and Richland, Washington sites, Barnwell alsoexperienced considerable problems with the waste shippers complyingwith transportation and packaging regulations and waste acceptancerequirements. Although the Barnwell site was not closed like theother two sites, significant legislation was passed to require compli-ance. This was a unique step for a state and it challenged interstatecommerce considerations. The law was designed to put the responsibil-ity on the generator of the waste rather than on the transporters.

On July 1, 1980, the South Carolina Low-Level Waste Transportation andDisposal Act was enacted. This legislation was somewhat controversialto waste generators. For the first time in regulatory history,persons having waste transported were required to secure a transportpermit, provide financial liability and give 3-day advance notice oftheir shipments. This legislation also subjected them to enforcementsanctions by the state in the form of civil penalties and permitsuspensions for noncompliance with federal and state regulations. In an effort to minimize the impact on waste generators, the statedevised a permitting and notification system that was reasonable andsomewhat simplified. This program has been extremely effective in themanagement of low-level waste and regulatory compliance. Nevada andWashington took similar action and required site use permits. TheSouth Carolina Department of Health and Environmental Control (DHEC)has collected well over one-half million dollars in regulatory finesand suspended permits on numerous occasions. Occurrences of noncom-pliance with federal and state transportation regulations and sitecriteria are now very seldom found.

The Barnwell site has experienced few operational problems. However,in 1992 it was determined that tritium was migrating from some of the

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earlier trenches at a rate greater than had been anticipated. Thiswas due mainly to the poor construction technique of the trenches, thelarge quantities of tritium placed in them, interlinking subsurfacesand lenses and above normal rainfall. The tritium plume with concen-trations that exceed EPA drinking water standards (which are notapplicable) is still confined to the facility operator's property, buthas moved past the burial site boundary. However, no public orprivate drinking water supplies are affected.

A very expensive and elaborate study was required by DHEC to determinethe extent of the tritium plume. This study continues to date, andextraordinary information has been gathered concerning groundwatermovement in this particular geological location that may be useful forother facilities. In addition, remedial action was required in theform of an enhanced cap over the affected trench area. This capincludes impermeable and semi-permeable synthetic materials, anddrainage layers that direct rainfall away from the site. Preliminaryindications show reduced tritium concentrations in the groundwaterwells adjacent to the trenches, and it is anticipated that in time,the tritium plume will no longer be supplied with a source from thetrenches.

2. Regulatory and Technical Changes

In 1978, the Barnwell, Beatty and Richland sites were the only facilitiesopen to commercial disposal of low-level radioactive waste. Federal standardsand regulations for shallow land disposal to this point were virtuallynonexistent except for minimal technical criteria. Essentially, the AgreementStates were responsible for regulating these disposal sites and developed thestandards and regulations through specific license conditions. Each site hadits own unique requirements. The evolution of low-level radioactive wastefrom minimally contaminated materials to high activity metal components andion exchange resins required the Agreement State regulatory agencies toestablish higher standards and complex requirements for disposal.

In the earlier years of operation, the facilities received waste with lowto moderate concentrations of radionuclides. The original submittal for alicense at Barnwell specified radiation levels from waste containers not toexceed 100 millirems per hour on contact. Today, stainless steel linerscontaining irradiated components have measured 50,000 rems per hour oncontact. Radiation levels are restricted to the shielding capacity of thetransportation casks and operational limits imposed by the facility operator.

Low-level waste received at these sites has evolved over the years frombarely detectable activity in dry active waste, evaporator concentrates, ionexchange resins and filter media to much higher activity waste. As theoperational lifetime of the commercial reactors increased, the waste streamloadings began to increase in radionuclide concentrations. Replacement ofmetal reactor components, power level monitors, poison curtains and othermetal fixtures contributed to a new waste stream of high activity radio-nuclides with extremely high radiation levels, such as cobalt-60. Due tothese increased concentrations and high activity components, new restrictionswere required to provide enhanced protection of the burial environment frommigration of radionuclides, and protection of site workers and transportworkers. Some of these restrictions were administrative in nature for better

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management controls, but others required innovative measures on the part ofwaste generators and their contractors to meet these new regulatory require-ments. For the most part, generators had the ability to comply with therequirements. Some took longer than others to effect changes in their wasteprograms. Eventually, all generators complied. However, the Agreement Stateagencies worked very closely with the burial facility operators, the wastegenerators and the NRC to formulate these requirements. 10 CFR 61 reflectsmany of these restrictions, which were vanguarded by the states of SouthCarolina, Nevada, and Washington.

Until October 1974, the burial sites received bulk shipments of liquidsfor on-site solidification prior to disposal. This allowance was made due tothe poor design of evaporators at most of the reactor sites. Many wastegenerators did not have the capability to solidify large volumes of water thatwere slightly contaminated. Therefore, they were allowed to ship theseliquids in large tankers for storage and processing at the burial sites. Thisconcept became quite controversial from a transportation standpoint and wouldhave had severe repercussions if an accident occurred and large quantities ofliquids were released. This practice was reviewed and determined not to be inthe best interest of the states from a public health standpoint. Thus, therequirement was initiated to solidify liquids at the point of origin.

The reactor sites objected to this decision. However, mobile solidifi-cation units were designed and put into operation at the reactors and perma-nent solidification units eventually were built. The generators were able tocomply with this restriction through the use of contractors, although it wasexpensive. Urea formaldehyde was selected as one of the solidification mediaof choice, but was eventually disallowed as a solidification media due to itsextensive hazardous and corrosive properties.

Following the accident at Three Mile Island (TMI) in 1979, a publicstatement was made that said, in effect, "any waste resulting from theaccident would probably be disposed at commercial sites." This invoked apublic and political outcry. Little was known at that time about the amountsof waste, what the waste would contain and the concentrations. Therefore, animmediate ban was imposed in South Carolina to prevent any waste from the TMIfacility from being disposed at Barnwell. This decision was later supportedby the analysis of certain waste that contained large concentrations offission products and transuranics. This action also caused a rethinking oflow-level waste, and a realization that stricter requirements would benecessary. Eventually, some waste was allowed into Barnwell and the othersites, but the bulk of high-activity waste was transferred to DOE facilitiesin Idaho.

Also in 1979, a ban on organic liquids such as scintillation fluidscontaining hazardous chemicals was imposed at Barnwell to avoid environmentalconsequences from the liquids' chemical properties and mobility. Hanford andBeatty continued to receive these wastes, but eventually phased them out aswell. Clearly, scintillation fluids with slight quantities of hydrogen-3 andcarbon-14 were overwhelmingly chemically hazardous. This proved to be a sounddecision, because mixed wastes under the provisions of the Resource Conserva-tion and Recovery Act (RCRA) were later prohibited. However, new regulationswere promulgated that allowed the disposal of nonhazardous fluids and recy-cling of the hazardous "cocktail" mixtures. This had a short but profound

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effect on research until the NRC established regulations to allow deregulationof these wastes from the radiological standpoint.

Through inspection efforts at the disposal sites, it was determined thatmany waste forms arriving at the burial facilities contained large quantitiesof freestanding liquids, and occasionally these liquids were found to becorrosive to the carbon steel waste containers. Not only did this causeconcern for the potential of radionuclide migration, it also presented aproblem during transportation due to leaking containers. Therefore, afreestanding liquid restriction of no more than 0.5 percent non-corrosiveliquids by waste volume was imposed. Further, due to the increased concentra-tions of radionuclides in ion-exchange resins and other filter media, allwaste containing radionuclides with half-lives greater than five years havinga specific activity of one microcurie per cubic centimeter or greater requiredstabilization by an approved solidification media. Prior to this, ion-exchange resins were allowed to be "dewatered"; however, this earlier processleft large amounts of residual liquids in the containers.

These new restrictions caused considerable controversy throughout thenuclear industry, and the Agreement State regulatory agencies were besiegedwith concerns over the ability of generators to meet these new sanctions. Even the NRC expressed its concerns. These objections were considered, and aphase-in schedule allowed the generators time to comply and acquire theequipment and/or services to meet these new requirements. Those utilitiesthat failed to make progress were prohibited from shipping their waste. Theresults of these restrictions were quite significant, but went a long way toprovide credibility for shallow land disposal. By Jan. 1, 1981, theserestrictions were fully implemented.

By November 1979 it was becoming increasingly evident that the Barnwellsite had become the major commercial low-level waste site in the nation,accepting more than 75 percent of waste transferred for disposal (not generat-ed). This was viewed by the political leaders of the state as an unacceptablesituation. Therefore, Governor Riley requested DHEC to impose a volumelimitation on Barnwell. This decision was twofold; not only was there concernabout the public's health from the impact of increased transportation, but thedisposal capacity for South Carolina-generated waste was being jeopardized.

Earlier, in January 1978, a volume restriction had been imposed not toexceed 2.4 million cubic feet per year. The November 1979 restrictionestablished a declining schedule that limited the site to no more than 189,000cubic feet per month, and by October 1981 the site could receive only 100,000cubic feet per month. This is now the current restriction of 1.2 millioncubic feet per year.

This plan also required a prior notification condition and an allocationscheme to insure that South Carolina interests were preserved and disposal ofits waste given priority. CNSI was responsible for administering the alloca-tion program based on the historical waste disposals made by all the genera-tors, and was closely monitored by the South Carolina radiation controlprogram.

The volume limit restrictions had a considerable impact on the nuclearindustry and almost created a panic situation, more so than the eventualitythat the Barnwell site would close at the end of 1992. However, waste

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generators again took innovative measures to solve the problem confrontingthem. Better waste management practices were devised such as segregation andcompaction. Advancements were made in waste processing such as extrusion,evaporation and solidification. Ion exchange resins were regenerated andloadings became heavier. However, there were some negative consequences tothis. Waste became higher in quantity of radionuclides and therefore morehazardous from a handling, transportation and disposal standpoint. Thisrequired further restrictions concerning containment of waste, as well asimprovements in handling techniques during disposal operations.

3. Impact of 10 CFR Part 61

Until 1983, there were no specific regulations at the federal or statelevel that established requirements for shallow land disposal of low-levelradioactive waste. There were general requirements in regulations thatprimarily required a review of the geohydrological conditions before authoriz-ing disposal of low-level waste with at least six feet of ground cover. Regulatory requirements were mainly specified in the specific radioactivematerial licenses issued by the Agreement States. Many of these licenseconditions were later promulgated in the Part 61 regulations.

In December 1983, 10 CFR Part 61 requirements were implemented fully atall the burial sites. Prior to the implementation of Part 61, all wastestreams were required to be properly quantified and qualified, and required anaccurate account of the radionuclide concentrations. Therefore, the genera-tors had established databases and formalized their process control programsto assure proper classification. Many generators were assisted by vendors whodeveloped elaborate computer codes. The impact of 10 CFR 61 on burialfacility operations was somewhat minimal due to the fact that many of therestrictions had been previously implemented by the states in phases, and itwas not a tremendous problem for the generators to comply with the newrestrictions.

The new regulations established, for the first time, waste classifi-cations based on radionuclide concentrations with specific half-lives andwaste form requirements. They also required the higher concentration waste,Classes B and C, which had to meet structural stability requirements, to besegregated from Class A waste with lower concentration, which did not have tobe structurally stable, in order to provide stable trenches. Specificcriteria also were established in the regulations which included performanceassessments, site characteristics and selection, and performance objectivesfor the site. The most important requirement, however, was the establishmentof the protection of the population from releases of radioactivity in thegeneral environment with an annual dose limit of 25 millirem (0.25 mSv) to thewhole body, 75 millirems (0.75 mSv) to the thyroid and 25 millirems (0.25 mSv)to any other organ. Other important performance objectives also were estab-lished, such as protection of inadvertent intruders by the use of engineeredbarriers, protection of individuals during operations, and stability of thedisposal site after closure.

4. Impact of the LLWPA of 1980 (P.L. 96-573) and the Low-Level Waste PolicyAmendments Act of 1985 (P.L. 99-240)

The LLWPA of 1980 was a very simple act establishing authority for statesto enter into compacts, establishing a federal government policy that each

18 During the crisis time of 1979, some observers suggested that the federalgovernment take responsibility for disposal of low-level wastes by shipping itto DOE sites. When DOE pointed out that if such were done, the wastes wouldlikely go to Savannah River (South Carolina), Hanford (Washington) and theNevada Test Site (Nevada) and it was likely those three states would object tocontinuing to be host states, albeit on federal government installations.

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state was responsible for disposal capacity and that LLW could be most safelyand efficiently managed on a regional basis. The initiative for this act camefrom a number of sources, including Governors Riley of South Carolina, Ray ofWashington, and List of Nevada, who were host to the then three operatingsites. In addition, on Feb. 12, 1980, President Carter established a StatePlanning Council by Executive Order. The council provided recommendations onseveral waste management issues and endorsed the principles established by theLLWPA of 1980. Other organizations such as the National Governor's Associa-tion and the National Conference of State Legislatures supported this ap-proach. Due to the lack of progress under this law, partly because of thelack of incentives for developing new sites, Congress passed the LLWPAA of1985. Neither of these acts provided any new health and safety regulatoryauthority to states; rather, they were designed to establish institutionalmechanisms for the development of new waste disposal capacity.

Congress enacted this legislation in an effort to have each state sharethe responsibility of managing and disposing of radioactive waste generatedwithin its borders, and to relieve the states of Nevada, South Carolina andWashington from this continuing burden.18 The legislation set forth therequirements to establish regional compacts with a designated host state andset a schedule of milestones the states were required to meet in order to havecontinued access to the operating burial facilities. The law also establishedsubstantial penalties to be paid to the three host states, and allowedsurcharges to be collected for use by the states with operating facilities forwhatever purpose they wanted.

As a result of this law, several compacts and unaffiliated states wereestablished. These entities are listed in Table 4 as they exist today. Thelaw also allowed the three sites to cease operating in December 1992. TheBeatty, Nevada site was closed and the Richland (Hanford), Washington sitelimited access to states in the Northwest and Rocky Mountain compacts. TheBarnwell, South Carolina site operating time was extended by the South Carol-ina General Assembly until June 30, 1994 for waste throughout the country, anduntil December 1995 for Southeast compact states only. However, the Barnwellsite could remain open to South Carolina-generated waste only beyond 1995.

The legislation also requires that each party state:

1. Establish the capability to regulate, license and ensure themaintenance and extended care of any LLW facility within itsborders.

2. Establish the capability to enforce any applicable federal orstate laws and regulations pertaining to the packaging and trans-portation of waste generated within or passing through its borders.

19 At the time this document was written, a bill had been introduced inthe U.S. Congress to approve the Texas LLRW Disposal Compact comprised ofTexas, Maine and Vermont with Texas designated as the host state.

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Table 4. Compact Members and Unaffiliated States

Unaffiliated Appalachian Midwest Northeast States19 Delaware Indiana *Connecticut Dist. of Columbia Maryland Iowa *New Jersey Maine*Pennsylvania Minnesota Massachusetts West Virginia Missouri Southeast Michigan

*Ohio Alabama New Hampshire Central Wisconsin Florida New York Arkansas Georgia Puerto Rico Kansas Northwest Mississippi Rhode Island Louisiana Alaska *North Carolina Texas*Nebraska Hawaii South Carolina Vermont Oklahoma Idaho Tennessee

Montana Virginia Central Midwest Oregon*Illinois Utah Southwestern Kentucky *Washington Arizona

Wyoming *CaliforniaNorth Dakota

Rocky Mountain South Dakota Colorado Nevada New Mexico

*Designated Host State

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3. To the extent authorized by federal law, require generators withinits borders to use the best waste management technologies and prac-tices available to minimize the volumes of waste requiring disposal.

The act also has had a rather significant effect on not only the regula-tory and management aspects of low-level radioactive waste, but waste technol-ogy as well. Most of the proposed facilities will incorporate above- orbelow-grade vaults for containment of waste packaged in concrete. This willsubstantially drive up the cost of low-level waste disposal from conventionalshallow land burial.

5. Conclusion

Regulation and management of low-level radioactive waste has evolvedsignificantly over the past 20 years from an obscure issue to one of the morecontroversial and important matters facing the states, radioactive materialusers and utilities today.

The Agreement States have played a vital role in the development ofregulations, criteria and standards for the safe disposal and isolation oflow-level radioactive waste. The future of this issue also will be in thehands of the states, and it is unfortunate that politics, not technology, isdelaying schedules for site development. It is also ironic that some of thepolitical leaders who were responsible for the development and passage of theLLWPAA are also the ones who now are trying to undo the process. If this isnot resolved soon, the nation will surely be in a dilemma with low-levelradioactive waste management and storage at the site of generation, which willhave profound health and safety repercussions. All states, not only AgreementStates, will have to face this issue with a lack of support from electedofficials and the public.

F. Regulation of Naturally Occurring and Accelerator-ProducedRadioactive Materials (NARM)

NARM have the same type radiation emissions as the radioactive materialsidentified in the Atomic Energy Act and pose similar threats to the publichealth and safety, and the environment.

Approximately 25 years ago, Jim Miller of FDA quoted Jane Addams who said,"Progress is not automatic. The world grows better because people wish thatit should and take the right steps to make it better. If things are ever tomove forward, somebody must be willing to take the first steps and assume therisk."

Almost every state that entered into an agreement with the AEC/NRCincluded a program for regulation of NARM sources. This reflected the states'recognition that ionizing radiation presented the same kinds of potentialhazards regardless of its source. The Mississippi actions regarding NARM areillustrative.

In early 1961, A. L. Gray, M.D., Executive Officer, Mississippi Board ofHealth, noted that although the Atomic Energy Commission regulated radioactivematerials under its jurisdiction and the state regulated x-ray, there was avoid in that radium and other naturally occurring radioactive materials werenot under the jurisdiction of any regulatory agency in so far as licensure was

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concerned. A plan was implemented in Mississippi whereby radium users wouldbe required to apply for and receive a license for the possession and use ofradium identical to that required by the Atomic Energy Commission for thematerials under its control. This plan included an agreement with radiumdistributing companies throughout the country and elsewhere whereby thecompany would not lease or sell radium to anyone within the state that did notpossess a license for that material. The public health significance of thismove was quite obvious. Why should a license be required for one millicurieof iodine-131 with a half-life of eight days and not for 100 millicuries ofradium-226 with a half-life of over 1600 years? The timing of the radiumlicensing program was intentional, since it was felt the publicity of theexpected AEC-Mississippi transfer of authority would make this new regulatoryprogram more palatable, especially to those who had never before been requiredto have a license. The state immediately began receiving requests forapplications for a radium license. This move did not prove to be premature,since subsequent inspections indicated that 30 percent of the radium sourcesinspected exhibited considerable leakage and contamination.

On Nov. 21, 1966, the Atomic Energy Commission (AEC) appointed a panel toreview the Commission's regulatory program for byproduct material. The panelsubmitted a report, the Trowbridge Report, to the Commission on Sept. 5, 1967. One conclusion it made was that the Atomic Energy Act provides authority forthe regulation of only a relatively small percentage of the sources ofpotential radiation hazard. The panel firmly believed that regulation of allsources of ionizing radiation should be conducted according to uniformstandards and procedures and under the aegis of a single federal agency.

To quote from a paper titled, "Health Physics Problems in Oil and Gas WellLogging," which was presented at the annual meeting of Agreement States andAEC in November 1966, "...because of the widespread use of radium and lack ofprevious government regulations concerning its use, careless handling methodsevolved. State inspectors have noted direct handling of 300 milligram radium-beryllium neutron sources with gamma exposure rates of 50 roentgens per hourat the surface of the source. To emphasize a misunderstanding of the problem,one company's operating procedures warned its personnel never to handle asealed radium-beryllium source with the bare hands but always to wear a pairof cotton gloves."

In 1970, the Interstate Relations Committee of the Conference of RadiationControl Program Directors (CRCPD) identified five areas where it felt actionwas needed (see reference 14, p. 325). The first area of concern was thelicensing of non-agreement material specifically related to radium distribu-tors. This would be the licensing of non-agreement materials in non-licensingstates. This was a new term that had been suggested rather than non-agreementstates, since there were two radium licensing states that were non-agreementstates.

One of 12 resolutions approved by the Agreement States in October 1972addresses a uniform program of control and licensure for both agreementmaterials and non-agreement materials. "All radioactive materials shouldreceive the same degree of control in all states. At the federal level,uniform and effective control can best be provided by a single agency;therefore, the General Accounting Office should recommend to the JointCommittee on Atomic Energy that the Atomic Energy Act of 1954 be amended to

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extend the authority and responsibility of the U.S. Atomic Energy Commissionto include all radioactive material."

Excerpts from page 65 of the 1972 GAO Report, B-155352, to the JointCommittee on Atomic Energy, Congress of the United States, from the Comptrol-ler General of the United States, indicate that "the states expressed concernabout the lack of comprehensive federal controls - or uniform and compatiblestate control - over NARM. No federal agency has comprehensive jurisdictionover users of such materials, even though the hazards are similar to those ofreactor-produced radioactive materials. In fact, according to the AEC and theDepartment of Health, Education and Welfare (HEW), radium is more hazardousthan most man-made radioactive materials."

At the 1974 All Agreement States Meeting, the Agreement States recommendedstrongly that the AEC or its successor agency move immediately to bringaccelerator-produced and naturally occurring radioactive material under itsjurisdiction.

On May 8, 1975, the Executive Committee of the Conference of RadiationControl Program Directors met with the NRC Commissioners and strongly urgedthe NRC to consider taking appropriate actions to place this type of materialunder the same control as is now applied to materials falling under the AtomicEnergy Act. In response, the NRC established a task force in January 1976 toreview the matter of regulation of these materials.

NUREG-0301, Regulation of Naturally Occurring and Accelerator-ProducedRadioactive Materials, was published in July 1977 by the NRC. It was recom-mended by the task force that the NRC seek legislative authority to regulateNARM because these materials present significant radiation exposure potentialand existing controls were fragmentary and non-uniform at both the state andfederal level.

In 1975, the Executive Committee of the Conference of Radiation ControlProgram Directors established a task force consisting of representatives fromseveral state radiation control programs with resource persons from the EPA toassess contamination by naturally occurring radionuclides. The Task ForceReport on Natural Radioactivity Contamination Problems was published by CRCPDin June 1977 and was later published by the EPA in February 1978 as NaturalRadioactivity Contamination Problem, EPA-520/4-77-015. Natural RadioactivityContamination Problem, Report No. 2, was published by CRCPD in August 1981.

On Feb. 24, 1977, a symposium on Radioactivity in Consumer Products washeld in Atlanta, Georgia. Papers were presented on products containing NARMand on the laws, regulations, standards and guides (see reference 12). InJuly 1977, the CRCPD published the NARM Guides for Naturally Occurring andAccelerator-Produced Radioactive Materials, FDA publication 77-8025.

At the 1982 All Agreement States Meeting, the Agreement States againdiscussed the problems associated with the non-regulation of NARM in non-agreement states and non-licensing states. The Agreement States stronglysuggested that the NRC petition Congress to amend the Atomic Energy Act toauthorize the regulation of NARM. A letter reflecting their concerns waswritten to the National Governor's Association to be included in theirAgreement States program assessment. The NRC response dated Dec. 9, 1982stated that, "we expect the subject of NARM regulation to be brought to the

20 In practice, this program only covers programs for regulation ofdiscrete sources of NARM.

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Commission's attention in connection with the consideration of the recommenda-tion of the NGA study, one of which we understand will deal with NARM." TheNational Governor's Association in its publication, The Agreement StateProgram: A State Perspective dated January 1983, states "The Atomic EnergyAct should be amended to authorize the regulation of radioactive materials notpresently affected by the Act, that is, NARM." (Reference 4, p. 5.)

The licensing state concept for the regulation of NARM conceived in 1976by CRCPD was finally developed and implemented in 1983. At present, there are15 states identified as "Licensing States." Each of the 15 states is anAgreement State. This program is one where CRCPD has determined that a statehas an effective program for regulation of NARM regardless of whether or notthe state is an Agreement State.20

At the 1984 All Agreement States Meeting, the states adopted a resolutionon NARM supporting the concept that the NRC should seek legislation toregulate discrete sources of NARM. The resolution stated, "That the Stateswhich have signed Agreements with the U.S. Nuclear Regulatory Commission,declare that it is in the best interest of the citizens of the United States,that naturally occurring or accelerator-produced radioactive material that isused or produced for its radioactive properties, or radioactive materialproduced incidental to such production, should be regulated by the U.S.Nuclear Regulatory Commission in an equal manner with Byproduct, Source andSpecial Nuclear Material." The NRC's response dated Dec. 4, 1984 stated, "InOctober 1984 we published NUREG-0976, an update of the original NARM study. Most of the original findings pointing to the need for uniform control wereconfirmed in the update survey. Also, there is the possibility of dualregulation of low-level waste disposal by NRC and EPA, due to potential EPAregulations of NARM disposal."

The CRCPD at its 17th Annual Meeting adopted a formal position relative tothe need for amending the Atomic Energy Act to authorize the NRC to regulateNARM. This was forwarded by letter dated June 6, 1985, to Nunzio Palladino,Chairman, NRC. Enclosed with the letter were suggested amendments for theAtomic Energy Act of 1954 and CRCPD's position paper on NRC Regulatory Controlof NARM.

At the 1986 All Agreement States Meeting, the Agreement States once againurged the NRC to work toward getting the Atomic Energy Act amended to includeall radioactive materials. Some states had investigated occurrences ofradioactive contamination associated with scale from tubing and other equip-ment that had been used in the production and processing of oil and naturalgas. The states felt strongly that the appropriate entity to regulate allradioactive materials was the NRC. The NRC responded in a letter datedDec. 16, 1986, that "... absent Commission directives to do so, the NRC staffhas no current plans to request congressional action to gain control of NARMor NORM. NRC has published two detailed reports on the regulation of thesematerials, NUREGs 0301 and 0976. Also, the Conference's program of ‘Licensing

21 This is presumably based on the EPA's general authority.

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States’ should help alleviate the NARM problem, if taken advantage of by theStates."

At the 1987 All Agreement States Meeting, encouraged by NRC ChairmanZech's commitment to take charge, the Agreement States again requested the NRCto regulate NARM and NORM. The states also requested the opportunity toreview the NRC staff paper on this subject and to be allowed to appear beforethe Commission regarding the NARM/NORM issues.

At the 1988 All Agreement States Meeting, it was expressed that theAgreement States have traditionally and appropriately recommended to the NRCthat NARM should be regulated by the NRC. It remains impractical and illogi-cal that NARM not have a home in a single federal agency. The NRC's responseletter dated Dec. 22, 1988, stated, "We acknowledge the comments of theAgreement States on NARM issues. As you know, NRC referred this question tothe Science Advisor to the President and the Committee on Interagency Radia-tion Research and Policy Coordination (CIRRPC) has agreed to review it and towork with the CRCPD."

In the CIRRPC Fourth Annual Report dated June 30, 1984, it is reportedthat the CIRRPC chairman, Alvin L. Young, met with the NRC to discuss apotential CIRRPC review of the NRC report, "Naturally Occurring and Accelera-tor-Produced Radioactive Materials - 1987 Review." In CIRRPC's Eighth AnnualReport dated December 1992, it is reported that a CIRRPC working group wascreated in response to a request from the Chairman of the NRC to the Directorof the Office of Science and Technology Policy (OSTP) to examine the need forfederal regulation of "discrete" sources of NARM. This request stemmed fromthe earlier requests by state radiation control program directors for the NRCto seek legislative authority to regulate NARM. The CIRRPC working groupdrafted a report that addressed the regulation of discrete NARM and noted thatthere are existing federal authorities to support any future need for suchregulation. The working groups did not identify risks due to NARM that wouldwarrant expanded federal authority. CIRRPC stated that existing federal andstate legislative authorities provide adequate public health protection forany likely risks from NARM. The CIRRPC Executive Committee informed the NRCand OSTP of its agreement with the working group's conclusion.

The chairman of the OAS recommended that all discrete sources of NARM bebrought under the federal regulatory scheme when he testified before the Synarsubcommittee on Aug. 2, 1993. More than 30 years have passed, and most Agree-ment State radiation control programs are regulating NARM as they do othertypes of radioactive materials. Notwithstanding all the efforts from individ-uals, states, groups, organizations, and state and federal agencies - federalstandards and regulations are non-existent for NARM even though CIRRPC statedthat sufficient federal authorities existed to support regulation.21

It would appear that no one at the federal level has taken seriously thenumerous concerns and recommendations made by the states. The longstandingfeeling of the federal agencies that naturally occurring radiation (God'sradiation) need not be regulated seems archaic. And when they put their mind

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to it, as in the case of uranium mill tailings (see section VIII.D above), thefederal government did decide it was worth regulating by enacting the UMTRCA.

Four states, Arkansas, Louisiana, Mississippi and Texas, have specificregulations addressing the licensing of NORM. Litigation regarding NORM inone state, Mississippi, is causing tension for the Radiological Health staff. As this document is being prepared, concerned citizens are requesting Missis-sippi legislative committees to investigate the NORM issue.

IX. Current Issues

A. Medical

Many of the current developments in the medical area have been covered inSection VIII.A. However, a few other points are worth mentioning.

When 10 CFR 35 was adopted by the NRC, it did not truly address qualityassurance in nuclear medicine departments. The issue was addressed in aseparate rulemaking that had the effect of reducing the reporting level formisadministrations of radiopharmaceuticals. The original 10 CFR 35 requiredmisadministration reports to be filed both for diagnostic and therapeuticmisadministrations. The medical quality control amendments removed virtuallyall diagnostic misadministrations from the reporting requirements. Unfortu-nately, in most of the public discussions during Congressional hearings, theimpression was left that the data reported by the original requirements wasinadequate, since it was not in accord with the newest regulation.

When 10 CFR 35 was being prepared for final publication, the AgreementStates became alarmed that the NRC staff was not sensitive to the existingrequirements in use in many states for nuclear medicine. Specific concernswere that the duties of the authorized user were changed, the licensee couldrevise his procedures without notice to the licensing agency, and physiciansnot specifically trained in nuclear medicine could order nuclear medicineprocedures.

The series of articles in the Cleveland Plain Dealer in late 1992 raised anumber of concerns about both state and federal programs for regulating usesof ionizing radiation. The articles covered occurrences involving bothradiation machines and radioactive materials. The resulting U.S. Senatehearing in May 1993 focused on these issues. As noted earlier, the NRC isinvolved in a major reevaluation of its medical regulatory program, which willin turn affect the Agreement State programs.

It appears this subject will receive increased attention by the NRC andthe Agreement States in the next few years.

B. Compatibility

This issue was covered in some detail in Section VII.

The agreements with the NRC require that both the Commission and therespective state use their best efforts to keep their programs compatible witheach other. Further, the language of the Atomic Energy Act is that a statemust have a program that is "adequate to protect the public health and safety"

22 The NRC's Office of General Counsel has stated in various fora that theNRC has the authority to revoke an agreement because of a lack of continuedcompatibility (e.g., see page 80 of reference 13).

23 The NRC published a draft adequacy and compatibility policy for commenton July 21, 1994 at 59 Federal Register 37269-37274.

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and compatible with the NRC before an agreement may be entered into by thestate and the NRC. Once the agreement is signed, the Atomic Energy Actrequires the state to maintain an adequate program, but does not say that theprogram must be compatible. This vagueness and differing interpretation bythe NRC began to cause concerns in that some federal requirements were notbeing implemented by the Agreement States.22 A new emphasis on compatibilityquickly indicated that a definition was needed, as well as a full understand-ing of what Congress intended with the Agreement States program.

The NRC has been working on a compatibility policy for some time, whichhopefully will establish a good foundation for our mutual efforts in thisregard.23 However, the differing interpretations of the compatibility provi-sions of section 274 may never be settled absent some court ruling.

C. Imports

Several incidents involving the importation of products containingradioactive material indicate a need to improve the ability to detect andcontrol such imports. This would help preclude the need for extensiveinvestigations by state and federal officials after the products have beenwidely distributed.

D. Decommissioning

Two efforts are required for this issue. One is the establishment oflevels, i.e., concentrations, contamination levels, or exposures, to which acontaminated piece of property must be cleaned in order to be released for useby the general public. Second is how to estimate the amount of money to beheld available by the licensee for use in decontaminating the piece ofproperty, including real estate. Some proposals by the NRC were inadequate tomeet state regulatory requirements.

For many years, states had asked the AEC/NRC to set clean-up standards forsoil in particular. The conventional response from the NRC was that theydeferred to the EPA to set a generic standard. The EPA's standard responsewas that this was a low priority task for them. The earliest record ofdiscussions at the Agreement State meetings on this issue was at the 1974meeting.

The NRC finally attempted to set such a standard by issuance of its BelowRegulatory Concern (BRC) policy on June 27, 1990. This was in response tosection 10 of the LLRWPAA of 1985. State reaction was mixed, but many wantedthe ability to set more stringent standards than those being proposed by NRC. After the U.S. Congress interceded, the NRC announced deferral of the BRCpolicy on July 30, 1991, and that it would initiate a consensus-buildingprocess on the issue. The NRC's initial attempt at this failed, and then it

24 Prior to 1993, on several occasions, the Agreement States had suggestedthat the NRC materials regulatory program be subjected to a review similar tothat for the agreement states.

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began a process with significant public participation in late 1992. Thisinvolved a series of workshops to discuss the issues and obtain views of theinterested participants. States, industry, public interest and environmentalgroups participated in these workshops. The NRC's efforts are currently inthe early rulemaking stage. Ironically, in 1993, the EPA began a rulemakingeffort somewhat in parallel with the NRC work. The states' concerns now arethat the two agencies may develop inconsistent rules, notwithstanding thepledges of the two federal agencies to work together to avoid duplication.

E. Integrated Materials Performance Evaluation Program (IMPEP)

As a result of the 1993 GAO report on the NRC/Agreement State program andthe August 1993 Synar hearing, the NRC has been developing a program forevaluating Agreement State and NRC regional materials regulatory programs on acommon basis.24 The NRC presented a program for discussion at the October1993 meeting of the Agreement States. The Agreement States' reaction to theproposal was negative, and concluded it needed extensive revision in bothconcept and details. A numerical grading system, which the states felt wasnot appropriate for this cooperative regulatory program, was of particularconcern, and they felt that such indicators could be misused or misunderstoodby persons not familiar with the elements needed to carry out effectiveradiation control programs. A March 1994 version of the proposal received bythe Agreement States is much improved, and appears responsive to many of theconcerns of the states. Further, the numerical ratings have been removed. The program is being implemented on a pilot basis initially. The pilotprogram involves the NRC's Regions I and II and the states of Utah, Illinoisand New Hampshire.

F. Federal Advisory Committee Act (FACA)

Although some indication of problems with the application of FACA to jointNRC/Agreement State efforts appeared earlier, the issue came to a head inSeptember 1993. Prior to this, the NRC had sometimes formed a working groupor task force to address a regulatory issue, and Agreement States providedmembers to such groups.

Two Agreement State representatives (Sharp of Texas and K. Allen ofIllinois) were members of an NRC task force created in 1992 to develop a NUREGdocument titled, "Management of Radioactive Material Safety Programs atMedical Facilities." In September 1993, Allen was informed (Sharp then wasretired from Texas) that her participation on the task force would be limitedand, in particular, she would not be allowed to participate in reachingconsensus positions by exercise of a vote. This was a result of internal NRCdiscussions on the applicability of FACA to such task forces. The OASproposed a solution to this issue at the August 1993 Synar hearing anddirectly to the NRC. There was little response to this matter by the NRCuntil a staff briefing of the Commission in early January 1994, when theCommission requested its staff to work on it. The Office of the GeneralCounsel submitted a report to the Commission on Feb. 4, 1994, which reflectedthe first serious thought given to the issue by the NRC. On Feb. 8, 1994,

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when the Chairman of the OAS briefed the Commission, the matter was alsodiscussed and the Commission seemed receptive to trying to resolve thismatter. The Executive Committee of the OAS and the Chairman of the CRCPD metwith NRC officials on June 14, 1994 to discuss this issue.

X. Epilogue

We know not what the future holds. Of one thing we are certain - therewill be change.

One purpose of studying historical events is to learn from them. Afterall, historical events, whether in our professional lives or our personallives, are what shape us and develop our character. The information discussedin this report can be used as a reference when future actions are considered.

All of us have seen many changes in the use and regulation of nuclearmaterials over the years. We are very much aware of the fragile nature of ourenvironment and the efforts exerted today by regulators and regulatees tocorrect past mistakes and prevent future ones. We should not fault ourpredecessors for conditions that, in retrospect, appear to have been handledinappropriately. They acted in good conscience with the knowledge andtechnical understanding of the time. Likewise, we expect our successors to doa better job, having the benefit of the experience we provide, because theirknowledge will have been expanded and because their technical capabilitieswill have been improved.

Thus, changes should be expected. We would hope that they are based on areasoned approach, pure motives, and an expectation of substantial benefit toall concerned.

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REFERENCES

1. Selected Materials on Federal-State Cooperation in the Atomic EnergyField, Joint Committee on Atomic Energy, Congress of the United States,March 1959.

2. Hearings Before the Joint Committee on Atomic Energy, Congress of theUnited States, Eighty-Sixth Congress, May 19, 20, 21, 22 and August 26,1959, Committee Report.

3. Final Task Force Report on the Agreement States Program, U.S. NuclearRegulatory Commission, NUREG-0388, December 1977.

4. The Agreement State Program: A State Perspective, National Governors'Association, January 1983.

5. Controlling the Atom, The Beginnings of Nuclear Regulation, 1946-1962,George T. Mazuzan and J. Samuel Walker, University of California Press,1984.

6. U.S. Nuclear Regulatory Commission, Policy Issue (Information) Paper,SECY-91-039, February 12, 1991.

7. April 1993 GAO Report, GAO/RCED 93-90, Better Criteria and Data Would HelpEnsure Safety of Nuclear Materials.

8. Regulation of the Barnwell Low-Level Radioactive Waste Disposal Facility,V. R. Autry, July 1993.

9. 1990 Update, Summary of Low-Level Radioactive Waste Disposal FacilitySiting Laws, University of Tennessee, January 1991.

10. Directions in Low-Level Radioactive Waste Management: A Brief History ofCommercial Low-Level Radioactive Waste Disposal, U.S. Department ofEnergy, October 1990.

11. NUREG/CR-1759, Vol. 1., Data Base For Radioactive Waste Management, Reviewof Low-Level Radioactive Waste Disposal History, November 1981.

12. NUREG/CP-0001, Radioactivity in Consumer Products, August 1978.

13. Committee on Government Operations, U.S. Congress, Report on Aug. 2, 1993Hearing on the NRC's Agreement States Program.

14. Proceedings of 2nd Annual Conference, Conference of Radiation ControlProgram Directors, April 26-29, 1970.

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APPENDIX A

LIST OF AGREEMENT STATES

State Effective Date of Agreement

Alabama October 1, 1966

Arizona May 15, 1967

Arkansas July 1, 1963

California September 1, 1962

Colorado February 1, 1968

Amended April 20, 1982 for Mills

Florida July 1, 1964

Georgia December 15, 1969

Idaho October 1, 1968NRC reasserted April 26, 1991

Illinois June 1, 1987Amended November 1, 1990 for Mills

Iowa January 1, 1986

Kansas January 1, 1965

Kentucky March 26, 1962

Louisiana May 1, 1967

Maine April 1, 1992

Maryland January 1, 1971

Mississippi July 1, 1962

Nebraska October 1, 1966

Nevada July 1, 1972

New Hampshire May 16, 1966

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APPENDIX A, con't.

State Effective Date of Agreement

New Mexico May 1, 1974NRC reasserted on Mills, June 1, 1986

New York October 15, 1962

North Carolina August 1, 1964

North Dakota September 1, 1969

Oregon July 1, 1965

Rhode Island January 1, 1980

South Carolina September 15, 1969

Tennessee September 1, 1965

Texas March 1, 1963Amended March 24, 1982 for Mills

Utah April 1, 1984Amended May 9, 1990 for LLW

Washington December 31, 1966Amended February 19, 1982 for Mills

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APPENDIX A, con't.

AGREEMENT STATES

By Year of Agreement

1962 Kentucky, Mississippi, California, New York

1963 Texas, Arkansas

1964 Florida, North Carolina

1965 Kansas, Oregon, Tennessee

1966 New Hampshire, Nebraska, Alabama, Washington

1967 Louisiana, Arizona

1968 Colorado, Idaho (NRC reasserted Idaho in 1991)

1969 North Dakota, South Carolina, Georgia

1971 Maryland

1972 Nevada

1974 New Mexico

1980 Rhode Island

1984 Utah

1986 Iowa

1987 Illinois

1992 Maine

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APPENDIX B

LIST OF ANNUAL JOINT MEETINGS

1962

1963

December 14-15, 1964 Washington, D.C.

November 17-18, 1965 Washington, D.C.

November 16-18, 1966 Washington, D.C.

November 15-16, 1967 Bethesda, Md.

October 21-22, 1968 Bethesda, Md.

October 20-21, 1969 Bethesda, Md.

October 19-20, 1970 Bethesda, Md.

October 18-19, 1971 Bethesda, Md.

October 16-18, 1972 Bethesda, Md.

October 16-18, 1973 Bethesda, Md.

October 8-10, 1974 Bethesda, Md.

October 7-9, 1975 Bethesda, Md.

October 5-7, 1976 Bethesda, Md.

1977

October 3-5, 1978 Silver Spring, Md.

October 2-4 1979

October 7-9, 1980 Atlanta, Ga.

October 20-22, 1981 Arlington, Tex.

October 27 1982 Gaithersburg, Md.

September 27-29, 1983 Arlington, Va.

October 2-4, 1984 King of Prussia, Pa.

October 8-10, 1985 Bethesda, Md.

October 7-9, 1986 San Francisco, Calif.

October 7-9, 1987 Louisville, Ky.

October 5-7, 1988 Potomac, Md.

October 11-13, 1989 Overland Park, Kans.

Oct. 30 - Nov. 1, 1990 Reno, Nev.

October 28-29, 1991 Sacramento, Calif.

October 26-28, 1992 Towson, Md.

October 24-27, 1993 Tempe, Ariz.

October 23-26, 1994 Portland, Maine

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APPENDIX C

CHAIRPERSONS

ORGANIZATION OF AGREEMENT STATES

1962

1963

1964

1965

1966 John Heslep, California *

1967

1968

1969

1970

1971 B. Jim Porter, Louisiana

1972

1973

1974

1975 Aubrey Godwin (then of Alabama)

1976 Al Hazle, Colorado

1977 Ellis Simmons, Nebraska

1978 Eddie Fuente, Mississippi

1979 Ted Wolff, New Mexico

1980 Charles Tedford (then of Georgia)

1981 John Vaden, Nevada

1982 Diane Tefft, New Hampshire

1983 Bill Spell, Louisiana

1984 Mike Mobley, Tennessee

1985 Joe Ward, California

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APPENDIX C (con't.)

1986 Ed Bailey (then of Texas)

1987 Frank Bradley, New York Department of Labor

1988 Larry Anderson, Utah

1989 Don Hughes, Kentucky **

1990 Greta Dicus, Arkansas

1991 Tom Hill, Georgia

1992 Tom Hill, Georgia ***

1993 Wayne Kerr, Illinois

1994 Bob Kulikowski, New York City Health Department

* There appears to have been a special meeting convened in this year todiscuss topics such as x-ray regulation.

** Chair-Elect Dicus presided over the 1989 meeting in Hughes' absence.

*** The Chair-Elect, Don Flater of Iowa, was unable to serve and Tom Hill was elected to a second term.

Historical Note: Eddie Fuente, Director, Division of RadiologicalHealth, Mississippi Department of Health, was absent from the 1993 All Agreement States meeting for the first time in 30 years. This is a record unmatched by any other program director.

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APPENDIX D COPY

United StatesATOMIC ENERGY COMMISSIONWASHINGTON, D.C. 20545

March 3, 1964

Mr. Charles R. BardenDirector, Radiation Control ProgramTexas State Department of Health1100 West 49 StreetAustin 5, Texas 78700

Dear Charles:

This is to confirm Bill Sims telephone conversation of February 24 concerningan exchange-of-information meeting at your office on Monday, March 23. Ifthis date is still convenient with you, we would like to have him meet withyou at 9:00 a.m.

Among other things, we would anticipate covering the following items:

1. Specific variations or exemptions from Texas regulations that have beengranted.

2. Problems encountered in reciprocal recognition of licenses.

3. The number of agreement materials licenses inspected according tocategories, including pre-licensing inspections or visits.

4. Inspection work load, number of re-inspections conducted, etc.

5. New procedures for evaluating license applications, new conditions of usethat have been included on Texas licenses, and new or unusual uses thathave been licensed or evaluated.

6. Use of medical consultation in evaluating applications for medical use ofradioactive materials.

7. Incidents and overexposures.

8. State experience in licensing naturally occurring and accelerator-produced materials.

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APPENDIX D COPY

Mr. Charles R. BardenPage 2March 3, 1964

9. Enforcement actions taken against licensees.

10. Personnel changes and present number of personnel regulating agreementmaterials. Additional training, if any, received by radiological healthpersonnel.

11. Specific types of information or assistance needed from the AEC.

12. Acquisitions of new facilities or equipment.

A copy of a suggested agenda is attached. We will appreciate your comments onthe agenda as well as the appropriateness of the suggested date at yourearliest convenience. If you have any particular questions which may involveadvance preparation on our part, please let us know.

Sincerely yours,

/s/

B. L.Harless, Chief

StateAgreements Branch

Division of Radiation Protection Standards

Attachment:Suggested Agenda

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APPENDIX D COPY

SUGGESTED AGENDA FOR TEXAS-AEC

EXCHANGE-OF-INFORMATION MEETING

Austin, TexasMarch 23, 1964

9:00 - 9:05 a.m. Opening Remarks - Texas

9:05 - 9:10 a.m. Opening Remarks - USAEC

9:10 - 9:45 a.m. Discussion of contemplated changes inUSAEC regulations

9:45 - 10:15 a.m. Discussion of contemplated changes inTexas regulations *

10:15 - 10:30 a.m. Break

10:30 - 11:15 a.m. Current AEC licensing activities

11:15 - 12:00 p.m. Current Texas licensing activities

12:00 - 1:30 p.m. Lunch

1:30 - 2:00 p.m. AEC experience in Compliance matters

2:00 - 2:30 p.m. Texas experience in Compliance matters

2:30 - 4:00 p.m. Exchange of Information - AEC and Texas

4:00 - 4:30 p.m. Presentation by AEC representatives ofsuggested changes to Texas regulations **

4:30 - 5:00 p.m. Tour of Texas Radiological HealthFacilities

* This item may or may not be appropriate, depending on whether Texas proposes any modification of its existing regulations.

** Prior to the meeting, AEC representatives will prepare a list of any modifications that have been made in AEC regulations which Texas may wish to consider incorporating in order to maintain our regulatory programs on a current basis.

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APPENDIX E COPY

United StatesATOMIC ENERGY COMMISSIONWASHINGTON, D.C. 20545

December 13, 1965

Mr. Charles R. Barden, P.E., DirectorDivision of Occupational Health and Radiation Control Texas State Department of HealthAustin, Texas 78756

Dear Charlie:

As discussed in my letter of July 15, 1965, to all Agreement States, and asBen Harless mentioned during the October 26-27 meeting in Austin, we plan tofurnish each Agreement State with our comments or suggestions concerning theState's program subsequent to each review meeting. The purpose of this letteris to supply our comments concerning the Texas program based on the Octobermeeting and the information which we continuously exchange with you during theinterval between meetings.

I would like to convey to you the very favorable impression gained by ourstaff with respect to the constructive and cooperative attitude exhibited byyou and your staff in our mutual efforts to fulfill the purpose of theagreement. Although our review disclosed no significant deficiencies in yourprogram, we would like to pass along to you the following comments which wefeel may be helpful.

We noted that in most cases inspection reports are not prepared other than asrecorded on your inspection findings form, which specifies the name of thelicensee, licenses inspected, date of inspection, items of noncompliancefound, and name of inspector. We understand that more extensive reports areprepared for incident investigations or in cases where major items of noncom-pliance are encountered. Although we realize that in most cases AgreementStates do not need to prepare inspection reports in the same detail that isnecessary under AEC procedures, you may wish to consider whether it would beuseful to your program to include in inspector's reports additional detail asnecessary to support items of noncompliance and findings with respect to theadequacy of the conduct of licensees' operations to protect health and safety. We feel such information is important in the event formal enforcement actionneeds to be taken and as a reference for future inspections and licensingactions. In most cases, it may suffice to summarize the inspector's notes andretain these summaries in the inspection files for future use.

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APPENDIX E COPY

Mr. Charles R. BardenDecember 13, 1965Page 2

We also understand that results of inspections are usually discussed at thetime of the inspection with the person immediately responsible for safety ofthe program, such as the radiation safety officer, and that letters ofnoncompliance are usually directed to the same person. We have found ituseful to discuss inspection results with a member of licensee management, whois in a position to assure that corrective measures are taken. Similarly,letters setting forth items of noncompliance have been addressed to the headof the licensee's organization. This practice has resulted, in part, from ourexperience which indicates that the heads of such organizations were often notaware of violations or unsafe practices and, therefore, were not in a positionto take corrective action. You may wish to consider whether a similarpractice would be useful in the administration of your program since weunderstand you have, in a few instances, experienced some delays on the partof licensees in taking appropriate corrective measures.

I hope that the foregoing comments will be useful to you in the administrationof your radiation control program. If you have any questions about them,please let us know. I would like to thank you again for the courtesiesextended to our representatives at the meeting.

Sincerely yours,

/s/

Eber R. Price, Director Division of State & Licensee Relations

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APPENDIX F

UNITED STATESNUCLEAR REGULATORY COMMISSION

WASHINGTON, D.C. 20555

April 3, 1992

Mr. W. Clough Toppan, ManagerRadiological Health ProgramState House, Station 10Augusta, ME 04333

Dear Mr. Toppan:

Under section 274g. of the Atomic Energy Act of 1954, as amended, the Commission is authorizedand directed to cooperate with Agreement States to assure that the Nuclear RegulatoryCommission (NRC) and Agreement State programs for protection against the hazards of radiationwill be coordinated and compatible. As a part of our mutual “best efforts" program to achievethese objectives, the NRC and the Agreement States have agreed to exchange certain informationon a periodic schedule.

I would like to inform you of the information currently being exchanged between the Commissionand the Agreement States and request that the State of Maine supply us with the same type ofinformation which the other Agreement States are now forwarding to us. The NRC will provideMaine with the following:

1. NRC regulatory guides pertinent to agreement materials.

2. NRC regulations (10 CFR), including proposed and effective amendments.

3. NRC and Agreement State sealed source and device registration catalog.

4. NRC and Agreement State licensing statistics and data on inspections and otherselected aspects of Agreement State programs.

5. Selected data on incidents in Agreement States.

6. Selected information related to escalated enforcement proceedings.

7. Copies of regulations published in the Federal Register by other Federal agencies, asappropriate.

8. NRC bulletins and information notices.

9. Responses to specific requests for procedural, technical, and regulatory informationconcerning the Commission's regulatory program.

10. NUREG reports of interest.

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APPENDIX F

Mr. W. Clough Toppan 2 APR 3 1992

The Commission also will supply, from time to time, additional information which we feel will be ofinterest to the Agreement States.

We would like the State of Maine to provide the NRC Office of State Programs with the followinginformation:

1. One copy of all licenses and amendments issued by the State (monthly).

2. Selected annual program information including statistical data on licensing andInspection activities per the All Agreement States Letter SP-92-038 (enclosed).

3. Updated statistical data and other programmatic Information which will be requestedin connection with the conduct of our periodic reviews of the Maine program.

4. Copy of each order or equivalent document issued in enforcement proceedings.

5. Draft proposed and effective regulations (2 copies, 2nd copy to Region I). Draftregulations should be furnished to us with at least a 60-day period for us to reviewand comment.

6. Copies of sealed sources and devices registrations issued by the State.

7. State Issued licensing guides and similar regulatory documents which may beprepared from time to time and which may be of interest to NRC and all AgreementStates.

8. Abnormal Occurrence Reports.

9. Miscellaneous Information as way be requested.

10. Information on significant incidents occurring in Maine involving licensed material.

I would appreciate confirmation that such information will he provided to NRC.

I appreciate your cooperation and that of your staff during our pre-agreement negotiations and wishto assure you of our commitment to he of assistance as necessary in the future. Please call Mr. Vandy L. Miller at (301) 504-2326 If you have any questions.

Sincerely,

Original signed by:Carlton Kammerer

Carlton Kammerer, DirectorOffice of State Programs

Enclosure:As stated

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APPENDIX G

NOT AN EXACT REPLICAAgenda

U.S. A.E.C.1717 H. St. N.W.Washington, D.C.

Room 1146Dec. 14-15, 1964

December 14

Opening

Meeting of Agreement State Representatives with Principal Staff

Regulation of Medical Uses of Isotopes

General Licensing of Diagnostic Uses

FDA-AEC-Agreement State Interfaces

Exchange of Information from Medical Advisory Committee

Contamination Levels for Facilities and Equipment Released for

Unrestricted Use

Waste Disposal

Status of Sea Disposal of LLW

Regulatory Problems Associated with Land Burial

December 15

Transportation of Radioactive Material

Guides and Regulations

Status of Regulations of Other Federal Agencies

Part 71

Part 72

General Discussion

Exchange of Licensing and Enforcement Data

Establishment of Film Calibration Lab

Report by Committee regarding Compliance Visits with State Inspectors

Evaluation of Agreement State Programs

Universal Label for Products

Sealed Source Device and Testing Program

Plans for Next AEC/Agreement State General Meeting

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APPENDIX H

MEETING AGENDA

1993 ALL AGREEMENT STATES MEETING

FIESTA INN2100 South Priest Drive

Tempe, Arizona

Sheldon A. Schwartz, ChairmanDeputy Director, Office of State Programs

Sunday, October 24. 1993

4:00 - 6:00 Discussion of Agreement State S. Schwartz, NRCCompatibility Policy

Monday, October 25. 1993

8:00 - 12:00 Agreement States/NRC Discussion S. Bahadur, NRCon New and Amended Regulations D. Cool, NRCState Participation in NRC Rulemaking C. Daily, NRC

12:00 - 1:00 Lunch

General Session

1:00 - 2:30 Opening Remarks A. Godwin, AZ

Welcome- John Kelly, Executive Assistant to Gov. Symington

“office of State Programs Richard L. BangartPerspectives” Director, OSP

“Training and Operation” Sheldon A. SchwartzDeputy Director, OSP

2:30 - 3:00 Break

3:00 - 4:30 Regulation - Part 20, Part 21 D. Cool, RESPart 34, Part 35Part 40.

4:30 - 6:00 Common Performance Indicators S. Schwartz, OSPF. Combs, NMSS

7:30 - 9:00 Part 61 Revisions/LLW Standards R. Bangart, OSP

1

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APPENDIX H

Tuesdav, October 26, 1993

8:00 - 9:30 Materials Regulation Panel R. Kulikowski, Chair

Medical Misadministration and C. Paperiello, NRCPatient Followup R. Kulikowski, N.Y.C.

Scaled Source and Device C. Paperiello, NRCEvaluations

Generally licensed Devices F. Combs, NRC

Food & Drug Administration/NRC S. Schwartz, NRCMemorandum of Understanding (MOU)

9:30 - 10:00 Break

10:00 - 11.30 Contaminated Sites Issues S. Collins, IL, Chair

NRC SDMP Program Status J. Austin, NRR

Agreement State Program Status S. Collins, IL

Sewerage System Contamination J. Austin, NRRR. Owen, Ohio

Site Decommissioning Funding Charles PiersonAssistant AttorneyGeneral, AZ

11:30 - 12:30 Lunch

12:30 - 2:30 NRC/EPA Interface Issues A. Godwin, Chair

Subpart I - Clean Air Act R. Bangart, NRC

Subpart T - Uranium Mill D. Sollenberger, NRC

Residual Contamination Standards D. Cool, NRC

2:30 - 3:00 Break

2

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APPENDIX H

3:00 - 4:00 Legal issues M. Malsch, NRCNRC Authority in Agreement States(1) Program Revocation(2) InvestigatoryLegal and Policy Considerations ofEarly State Involvement in theDevelopment of NRC Rules and Policies

4:00 Agreement States Meeting

Wednesday. October 27. 1993

General Session

8:30 - 9:30 Radioactive Waste Panel William Sinclair, Chair

Land ownership Issue W. Sinclair, Utah

Compact Revisions

9:30 - 10:00 Break

10:00 - 11:30 Operational Events Panel P. Merges, Chair

Gamma Knife Misadministration R. Quillin, CO

Source in Steel Mills P. Merges, NYS DEC

Abnormal Occurrence Reporting & S. Pertijohn, AEODNational Materials Events Database

11:30 - 12:00 Meeting Summary Remarks G. Wayne Kerr, IL

12:00 Meeting Adjourns - Staff Meeting

3